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CLINICAL EVALUATION OF VATSAKADI QWATHA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO DIABETES MELLITUS (NIDDM), SRIKRISHNA H.A, PG Studies in Kayachikitsa, A.L.N. Rao Memorial Ayurvedic Medical College and …

CLINICAL EVALUATION OF VATSAKADI QWATHA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO DIABETES MELLITUS (NIDDM), SRIKRISHNA H.A, PG Studies in Kayachikitsa, A.L.N. Rao Memorial Ayurvedic Medical College and P. G. Centre, Koppa.

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  • 1. CLINICAL EVALUATION OF VATSAKADI QWATHAIN THE MANAGEMENT OF MADHUMEHA W.S.R TO DIABETES MELLITUS (NIDDM) BY Dr. SRIKRISHNA H.A BAMS (RGUHS) Dissertation submitted to theRajiv Gandhi University of Health sciences, Karnataka, Bangalore In partial fulfillment Of the requirements for the degree of Ayurveda Vachaspati” M.D. [Ayurveda] In KAYACHIKITSA GUIDE Dr. SURESH R.D M.D. (Ayu), MS (C&P), CYS.DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE KOPPA – 577126, CHIKMAGALUR DISTRICT KARNATAKA, INDIA NOVEMBER - 2010
  • 2. Department of Post graduate A.L.N.Rao Memorial AyurvedicStudies in KAYACHIKITSA Medical College Koppa – 577126 Dist: Chikmagalur Declaration I hereby declare that this dissertation entitled “Clinical Evaluation Of Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus (NIDDM).” is a bonafide and genuine research work carried out by me under the guidance of DR.SURESH.R.D. Department of Post Graduate Studies in KAYACHIKITSA, A.L.N. Rao Memorial Ayurvedic Medical College P. G. Centre, Koppa Date: DR.SRIKRISHNA H.A Place: Koppa P.G.SCHOLAR, Dept. of Kayachikitsa A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126
  • 3. Department of Post graduate A.L.N.Rao Memorial AyurvedicStudies in KAYACHIKITSA Medical College Koppa – 577126 Dist: Chikmagalur Certificate This is to certify that the dissertation entitled “Clinical Evaluation Of Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus (NIDDM).” is a bonafide research work done by DR. SRIKRISHNA H.A, in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD) in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka. Date: DR SURESH R.D Place: Koppa M.D (Ayu), MS (C&P), CYS GUIDE & ASSISTANT PROFESSOR Post graduate Department of Kayachikitsa A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126Department of Post graduate A.L.N.Rao Memorial AyurvedicStudies in KAYACHIKITSA Medical College Koppa – 577126 Dist: Chikmagalur
  • 4. Certificate This is to certify that the dissertation entitled “Clinical Evaluation Of Vatsakadi Qwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus (NIDDM).” is a bonafide research work done by DR. SRIKRISHNA H.A, in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD) in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka. Date: DR. DEBAJIT BHATTACHARYA Place: Koppa M.D. (Ayurveda) H.O.D. & PROFESSOR Post Graduate Department of Kayachikitsa A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126Department of Post graduate A.L.N.Rao Memorial AyurvedicStudies in KAYACHIKITSA Medical College Koppa – 577126 Dist: Chikmagalur
  • 5. EndorsementThis is to certify that the dissertation entitled “Clinical Evaluation Of VatsakadiQwatha In The Management Of Madhumeha W.S.R To Diabetes Mellitus(NIDDM).” is a bonafide research work done by DR. SRIKRISHNA.H.A,in partial fulfillment of the requirement for the degree of Ayurveda Vachaspati (MD)in KAYACHIKITSA of Rajiv Gandhi University of Health Sciences, Bangalore,Karnataka.Date: Prof. DR.SANJAYA.K.S. B Sc, MD (Ayurveda)Place: Koppa PRINCIPAL, A.L.N.Rao Memorial Ayurvedic Medical College, Koppa –577126
  • 6. COPYRIGHT I hereby declare that the Rajiv Gandhi University of Health Sciences,Karnataka shall have the rights to preserve, use and disseminate this dissertation inprint or electronic format for academic/research purpose.Date: DR.SRIKRISHNA.H.A P.G.Scholar,Place: Koppa Dept. of Kayachikitsa A.L.N. Rao Memorial Ayurvedic Medical College, Koppa – 577 126© Rajiv Gandhi University of Health Sciences, Karnataka
  • 7.   ACKNOWLEDGEMENT Salutations and surrenderence of this whole work under thelotus feet of his highness and holiness Sri Sri Sri RangapriyaMahadesikan and his highness and holiness Sri Sri SriSwayamprakasha Sachidananda Saraswathi Mahaswamiji. Salutations and surrenderence to the self within belovedparents, Sri.H.S.Ananthashayanam (Retired Manager, ING VYSYABANK and Smt.M.S.Vedavalli (Retired Headmistress), innateselfmate Mr. Srinidhi H.A and sister-in-law Smt Dr Janaki, SriSitaram Bhat and Smt. Nagaratna and all my other family memberswhose constant blessings through true - love, support, sacrifice,encouragement and inspiration has sculptured this whole worktowards its smooth and successful completion. Salutations and surrenderence to the self within beloved greatteachers Dr Rangapriya Mahadesikan, Dr.N. Shivarama Gayathri,Dr. Shobha. G. Hiremath, Dr Geetha Bhai, Dr Ahalya who taught andwill be teaching the essential lessons of Ayurveda for lifetime. Salutations and surrenderence to the self within beloved andrespected Guide Dr. Suresh. R. D, M.D (Ayu), MS (C&P), , P.G Dept. of CYSKayachikitsa, A. L. N. Rao Memorial Ayurvedic Medical CollegeKoppa for his blessings through high esteemed standards of guidance,meticulous supervision, timely advices, motivation, inspiration and co-operation throughout the successful completion of this dissertationwork. Salutations and surrenderence to the self within beloved andrespected Sri. Aroor Ramesh Rao, President, A.L.N. Rao MemorialAyurvedic Medical College, Koppa for giving an opportunity topursue post-graduate study in his esteemed and prestigious institution. Salutations and surrenderence to the self within beloved andrespected Dr.Sanjaya.K.S M.D , Principal, A.L.N Rao Memorial (Ayu)Ayurvedic Medical College, Koppa for his immense help and supportin completing this work. Salutations and surrenderence to the self within beloved andrespected Dr. Debajith Bhattacharya M.D (Ayu) , HOD and Professor, P.GDepartment of Kayachikitsa and Prof. Dr P.K. Mishra M.D (Ayu) , 
  • 8.  Department of Kayachikitsa for their blessings through great heartyinspiration. Salutations and surrenderence to the self within beloved andrespected P.G staffs in the Dept. of Kayachikitsa; Dr.Prasanth G.S M.D , Dr.C.B.Singh(Ayu),PhD M.D (Ayu) , Dr. Rita Singh M.D (Ayu) , Dr. Srinivas M.D (Ayu) ,Dr. Shobha Shetty M.D (Ayu) , Dr.Niranjan, M.D (Ayu), Dr.Smitha Manoj M.D , Dr Usha Rani(Ayu) M.D (Ayu) Dr Triveni M.D (Ayu) and Dr. Shobha. R. ItnalM.D (Ayu) . Salutations and surrenderence to the self within beloved andrespected Prof. T.K.Mohanta M.D, PhD (Ayu) and Prof. R.R. Mishra, , M.D (Ayu)for their substratal constructive suggestions during the successfulcompletion of this Dissertation work. Salutations and surrenderence to the self within beloved andrespected Prof. Dr D.K.Mishra , HOD of Bhaishajya Kalpana & M.D (Ayu)Assistant Principal of P.G faculty and Prof. Dr Vidyasagar M.D (Ayu) ,HOD of Dravyaguna for their constant encouragement and valuablesuggestions. Salutations and surrenderence to the self within beloved andrespected Dr. Prashanth Kumar Jha DIM, CIPR, PGDEE, MSc, Ph.D . Head, QualityControl Laboratories, for his guidance and support for Phyto ChemicalAnalysis without which the study would have been incomplete. Salutations and surrenderence to the self within beloved andrespected Prof. Dr H.R.Pradeep M.D (Ayu) Assistant Principal of U.Gfaculty and other P.G. faculty of Dravyaguna Department;Dr.Ilanchezhian , Dr.Harivenkatesh M.D (Ayu) M.D (Ayu) , Dr Vinayak BhatM.D (Ayu) and Dr.Bhanu M.D (Ayu) for their extensive help in the drugreview. Salutations and surrenderence to the self within beloved andrespected Dr.Mathapati M.D (Ayu) , Dr. Milind Hukkeri , Dr. Roshy M.D (Ayu)M.D (Ayu) , Dr. Harikrishnan M.D (Ayu) , Dr. Abdul Kareem M.D (Ayu) , Dr. ShubhaShastry M.D (Ayu) and Dr. Sandeep Sarode M.D , Department of (Ayu)Bhaishajya Kalpana for their guidance in the preparation ofmedicine. Salutations and surrenderence to the self within beloved andrespected Dr. Suryakumar, M.D (Ayu) , Dr Basavaraj M.D (Ayu) , Dr VidyavatiM.D (Ayu) from the Department of Shalakya Tantra, Dr. Laxmikanth M.D 
  • 9.  (Ayu) , Dr. Vikram M.D (Ayu) , Dr. Mithun M.D (Ayu) and Dr. Satish M.D (Ayu),from the Department of Shalaya Tantra for their support in thedissertation work. Salutations and surrenderence to the self within beloved andrespected Dr. Suhas Shetty, , for his kind inspirational attitude M.D (Ayu)and meticulous guidance in statistical work. Salutations and surrenderence to the self within beloved andrespected Dr. Ram Mohan, and Dr. Shanbhag, Consultant Physiciansof this bonafide Ayurvedic college and hospital for their supportduring various stages of this work. Salutations and surrenderence to the self within Dr. Sandhya,M.D (Ayu) , Dr. Elizabath, , Dr. Sonmankar, M.D (Ayu) M.D (Ayu) , Dr. Basavaraj,M.D , Dr. Moharar (Ayu) M.D (Ayu), Dr. Rashmi Sharma M.D , Dr. (Ayu)Saraganachary M.D (Ayu) and Dr. Prashanth.K , for their moral M.D (Ayu)support during the study tenure. Salutations and surrenderence to the self within the treasurest,the sweetest reminiscences of loving and affectionate sharing andcaring attitude shown by our dear seniors Dr. Nagendra M.D (Ayu) , Dr.Sreejith , by dear loving batchmates Dr. Bejoy, Dr. Lovelin M.D (Ayu)eralil, Dr. Krishnaveni, Dr. Thulya, Dr. Sriparvathi, Dr. Deepa, Dr.Ananda Bhairavi, Dr. Pallavi, Dr. Katyayani, Dr. Kiran, Dr.Jagadish Mayya, Dr. Narappa Reddy, Dr Vaishnavi, by dear lovingjuniors Dr. Suresh, Dr. Sudev, Dr. Subin, Dr. Jayakrishnan, Dr.Neelakantan, Dr. Divya Khare, Dr. Dhanyamurali, Dr. Soumitkumar, Dr. Parag, Dr. Kanchan kulkarani whose warmth hearty andintellectual memories will always be cherished as the ei-force, besidesjust being the e & i forces for the successful completion of this work. Salutations and surrenderence to the self within all the patientswho were included and excluded during the study for being theprimordial ei-force for the present and the future endeavours. Salutations and surrenderence to the self within all the hospitalstaff, pharmacy staff and especially for Ms. Amrutha and Mr.Mohana, the Lab technicians for their immense hearty andintellectual support for the successful completion of this work.Koppa, Nov. 2010. Dr. Srikrishna.H.A 
  • 10.   ABSTRACT Madhumeha is a term considered for the condition of all types of Prameha and specifically for one among the Vatika Prameha as elucidated by Acharya Chakrapani in Charaka Samhita and is characterized by Prabhuta and Avila Mutrata as the Samanya Lakshana. With specific Madhumeha lakshanas, some Ayurvedic scholars correlate Madhumeha with Diabetes Mellitus, which is a metabolic disorder characterized by hyperglycemia with or without Glycosuria resulting from an absolute or conditional deficiency of insulin. Madhumeha which has been correlated with Diabetes Mellitus has become a global health threat inspite of advances in conventional science; while, India has been projected by W.H.O as the country with the fastest growing population of Diabetic patients. Recent studies have estimated that in the year 2000, 171 million people had diabetes and are expected to double by 20301. So, in an attempt for early diagnosis and to combat this disease condition effectively; a formulation, Vatsakadi Qwatha mentioned in Sharangadhara Samhitha, Qwatha Kalpana Adhyaya in the context of Mehagna qwatha, has been selected for the present study based on the hypothesis that the drugs like Vatsaka, Triphala, Daruharidra, Musta and Bijaka having Tikta Kashaya as the Pradhana Rasa and Mehagna property are potent enough to combat this disease condition and are also easily available. OBJECTIVES:• To evaluate the efficacy of the formulation, Vatsakadi Qwatha in the management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM).• To assess the merits and demerits of the trial drug, Vatsakadi Qwatha.
  • 11.  • Detailed study of the disease covering classical and modern literatures.• To evaluate the Diabetic Quality of life. METHODS: Cases presenting with classical sign and symptom of Madhumeha were selected. The preparation Vatsakadi Qwatha had been given to a group of 20 patients. The symptoms of Madhumeha like Prabhutamutrata, Avilamutrata, Pipasa, Kshudha etc had been assessed before and after the treatment. The duration of the study was 45 days with 90 days follow up study with assessment of results at the interval of 15 days. RESULTS: The drug Vatsakadi Qwatha showed significant results in combating the symptoms of the disease Madhumeha during treatment period. The follow up results were insignificant. CONCLUSION: The Polyherbal formulation Vatsakadi Qwatha was effective in the management of Madhumeha during treatment period and was not effective enough during the follow up period. The ingredients of the formulation are easily available; needs constant discrete observation over the subject by the treating physician and has a wide scope for further studies. KEYWORDS: Madhumeha, Diabetes Mellitus, Vatsakadi Qwatha.
  • 12. CONTENTSSL. NO. TOPIC PAGE 1. Chapter- I INTRODUCTION 1 2. Chapter- II OBJECTIVES 4 3. Chapter- III REVIEW OF LITERATURE a) HISTORICAL REVIEW 5 b) DISEASE REVIEW 11 c) DRUG REVIEW 90 4. Chapter- IV METHODOLOGY a) MATERIALS & METHODS 99 b) OBSERVATIONS 110 5. Chapter- V RESULTS 128 6. Chapter- VI DISCUSSION 139 7. Chapter- VII CONCLUSION 164 8. Chapter- VIII SUMMARY 166 9. REFERENCE 10. BIBLIOGRAPHY 11. ANNEXURE
  • 13.   ABBREVIATIONS 1. A.Hr Ashtangahrudayam 2. A.Sa Ashtangasangraham 3. Cha.Sam CharakaSamhitha 4. Su.Sam Susrutha Samhita 5. Ma.Ni Madhava Nidanam 6. Sha.Sam Sharangadhara Samhitha 7. Ka.Sam Kashyapa Samhitha 8. Ha.Sam Harita Samhitha 9. Bha.Pra Bhavaprakasam 10. Y.R Yogaratnakaram 11. H.P.I.M Harrisson’s Principles of Internal Medicine 12. D.P.P.M Davidson’s Principles and Practice of Medicine 13. Ni Nidanasthanam 14. Chi Chikitsasthanam 15. In. Indriyasthanam 16. Vi Vimanasthanam 17. U. Utharardham 18. R.V Rig-Veda 19. S.B Shayana Bhashya 20. C.D Chakradutta 21. R.P Robbins-Pathology 22. K.V.K.C.M Clinical Medicine - K.V.Krishnadas 23. Chak Chakrapani 24. Ni.Sam Nibandha Sangraha 
  • 14. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) INTRODUCTION || िन या: ूाणभृतां दे हे वात प कफा य: । वकृ ताः ूकृ ितःथा वा तान ् बुभु सेत प डतः ॥ - च.सू.१८/४८ In an attempt to dig out the secrets of healing within the asylum of diseases;the therapeutic pearls of wisdom in the form of aphorisms delivered by our AncientAyurvedic Seers several thousand decades ago is now still on the verge of greatdiscoveries and achievements, under the sacred healing hands of the present dayAyurvedic Professionals of varied specialties. The Prime Eternal Objective Instinct of these professionals being the Quest Ofthree fundamental humors in relationship with the elan vital governing both Healthyand Non-Healthy state of the Human Body, Mind and Soul, thus guiding them to thegreatest heights of professional success by fulfilling the four essential pursuits of life1. Thus, literally, the word Ayurveda cannot be restricted to be defined as only –Science of Life but, it would be wise enough to be extended as the Most ScientificEternal Divine Coded Medical Language which teaches the value of being healthyand the means to achieve it through our day to day activities of life. This is achieved by the Ayurvedic professionals with the help of the fouressential limbs of therapeutics like the Bhishak, Dravya, Upastha and Rogirespectively, termed as Bhishak Chatushpada by the ancient seers. The present 21stcentury is gradually and drastically changing the attitude ofevery individuals of the society towards every aspect of life by guiding and promptingthem towards a weird quality of day to day physical and mental activities and finallymaking them to lead an obsessive, erratic lifestyle which in turn has led to an healthcrisis of various lifestyle disorders. One among those lifestyle disorders isMadhumeha vis a vis Diabetes Mellitus, which is now becoming a major health threatin both developed and developing countries. Statistically, India is now considered as ‐ 1 - 
  • 15. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)the diabetic capital and is sure to double from the 2010 - 171 million diabetics by2030. Acharya Charaka has quoted “as the birds are attracted towards the treewhere their nests lies, similarly Madhumeha affects people who are voracious eatersand have aversion to physical exercise. The disease Madhumeha, its definition,etiology, clinical features and principles of treatment appear to be similar with thedisease “Diabetes Mellitus”, which is considered as “Ice Berg” disease in the presentera1. Our classics have termed Madhumeha1 as Asadya keeping in terms of VatajaPrameha and also as a Kulaja Vikara - Jataja but, the term here in the present study istaken in accordance to the opinion of Acharya Chakrapani where Meha Samuha canalso be termed as Madhumeha and by the timely intervention with appropriateOushadha, Pathya and Vyayama for the same both the short-term and long-termcomplications can be effectively managed and prevented by breaking the viciouscycle of pathology and thereby enhance the Quality Of Life of the patient. If it is notdone so; then, the disease pathology progresses enough to gain a strong chronicity andbecomes Asadya. Ayurveda proposes number of Herbal and Herbo-mineral formulations for themanagement of Madhumeha. Here a sincere attempt has been made to provide abetter management of this dreadly condition, Madhumeha. The present research workundertaken is entitled as “Clinical Evaluation of Vatsakadi Qwatha in theManagement of Madhumeha With Special Reference to Diabetes Mellitus” basedon the hypothesis that the formulation Vatsakadi Qwatha11 mentioned inSharangadhara Samhita, Madhyama khanda, 2nd Chapter- Qwatha Kalpana Adhyaya-Mehagna context, with its ingredients Vatsaka1, Haritaki, Amalaki, Vibhitaki, ‐ 2 - 
  • 16. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Daruharidra, Musta and Bijaka have Tikta Kashaya Rasa Pradhanata andMehagna property. The present work also includes theoretical aspects of Madhumeha, briefhistorical review, Nirukti and Paribhasha, Nidana Panchaka, Bheda, Sapeksha Nidana,Chikitsa, Upadrava, Sadhya Asadhyatha as explained by different Ayurvedic classicsand also its modern parlance. Random selection of patients for clinical study, case study, adopted treatmentand its methods with respective subjective and objective parameters, resultsdiscussion and conclusion are dealt at the end in detail. Thus the entire work has been strategized chapter wise in the followingmanner: Chapter I Introduction Chapter II Objectives Chapter III Review of literature Chapter IV Methodology Chapter V Observation Chapter VI Results Chapter VII Discussion Chapter VIII Conclusion Chapter IX Summary Bibliography Annexure ‐ 3 - 
  • 17. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)   OBJECTIVES The study is based on the following aims and objectives.1) To assess the efficacy of ‘Vatsakadi Qwatha’ in the management of Madhumeha.2) To assess the merits and demerits of the drug.3) Detailed study of the disease covering classical and modern literature.4) To evaluate the Diabetic Quality Of Life. HYPOTHESIS  1. Null Hypothesis: Vatsakadi Qwatha does not have any effect in the management of patients suffering from Madhumeha.2. Alternative Hypothesis: Vatsakadi Qwatha do have effective role in the management of patients suffering from Madhumeha. ‐ 4 ‐   
  • 18. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) HISTORICAL GLIMPSES Study of sequential evolution of an event forms the fremost step in the field ofresearch. Study of history is of great important to know about the systematic development andprogress of the subject to determine the future plans for further establishment and researchdesigning. History of Medicine starts from the very moment when the human beings cameinto existence. Among the various ancient treatises, Ayurveda provides an extensive andemeritus description of diseases and their treatment. Here an attempt to review all theAyurvedic and Modern Treatises providing information related to historical background ofMadhumeha has been made. The evolution of Madhumeha can be traced right back from Vedas but, inrudimentary form. When we go through the Atharvaveda there is a reference related to thedisease Asrava along with its management. Sayana Acharya in his Sayana Bhashya revealsthat Asrava means Mutraatisara, the English translator Whitney (1962) interpreted it as fluxand Griffith (1962) as morbid flow, while leeman has translated the meaning of Asrava asDiabetes Mellitus. Sayanacharya has highlighted the vatic nature of this ailment.(A) Samhita Period: Elaborative description of the disease Meha viz-a-viz Prameha- Madhumeha has beenfound during Samhita period.(1) Charaka Samhita: Ref Cha. Ni. 4, Cha. Chi. 6 In this ancient treatise of medical science, Charaka has explained the Etiology,Pathogenesis, Prodromal Symptoms, Clinical Features, expected Complications anddescriptive therapeutic procedures with discretion – Sutra Sthana 17th chapter, Nidana Sthana4th chapter, Chikitsa Stana 6th chapter. -5- 
  • 19. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)(2) Sushruta Samhita: Ref. Su. Ni. 6, Su. Ni. 11, 12,13. Acharya Sushruta has contributed that the disease Prameha which when not treated atappropriate time gets transformed into Madhumeha in Nidana Sthana – 6th chapter, the wholedisease and its therapeutic purview in Prameha – Pramehapidaka – Madhumeha in ChikitsaSthana – 11th, 12th, 13th chapters successively. The distinct feature is the usage of KsaudraMeha instead of Madhu Meha in vatic variety in Nidana Sthana 6th chapter, Specificdecoctions for specific type Prameha and mentioned the Specific Dietary Pattern whichshould be avoided and to be used accordingly in Chikitsa Sthana.(3) Vagbhata Samhita: Ref. A.Hr. ni.10,A.Hr.12 Vagbhata has mentioned 2-3 types of underlying cause leading to Madhumeha i.e.Dhatukshaya and Avrutapatha or even both and added Sveda as one among the Dushya inNidana Sthana 10th chapter.(4) Harita Samhita: Ref Ha.Sam. II sthana 1/9 Acharya Harita has mentioned the cause as Papajanya and enumerated 13 types ofPrameha with nomenclature different than above treatise like, Puyameha, Ghrutameha etc.(5) Bhela Samhita: He described Prameha is of two type i.e. Svayamkruta and Prakruta Meha.(6) Kashyapa Samhita: He has mentioned the symptoms of juvenile diabetes clinical findings in VedanaAdhyaya and noted the disease as Chirakari. -6- 
  • 20. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)(B) MEDIEVAL PERIOD: In this period commentaries mainly written, but most of them content only thecollection of thoughts from previous authors.(1) Madhavanidana: Ref. Ma. Ni. 33 He collectively repeated the description of Charaka, Susruta and Vagbhata.(2) Gayadasa: Ref. Nyaya Chandrika Su. Ni.6/6 He has explained that the Samalatva of the Mutra is due to the presence of Dusya inMutra.(3) Sharangadhara Samhita: Ref. Sha. Ma.11 He has mentioned the 20 types of Prameha in Prathama Khanda 7th chapter, while wefind various scattered references with respect to the disease and the respective formulationsfor the latter in different forms. The Polyherbal formulation for the present study has beenselected from Qwatha Kalpana Adhyaya of the present treatise mentioned in MadhyamaKhanda. Meha Prakarana.(4) Bhavaprakasa: Ref Bha. Ni. Ma. Kha. 38 He describes Prameha and Madhumeha along with some new Herbo-Mineralpreparations.(5) Yogaratnakar: He has explained Prameha and Madhumeha along with its respective treatment. -7- 
  • 21. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) MODERN REVOLUTION AND THERAPEUTIC LANDMARKS:Some of emeritus inventive landmark about the Diabetes Mellitus:(1) Areatus (Christian era) : Firstly he mentioned the disease as Diabetes.(2) William Cullen - 1709 A.D : Added suffix mellitus to the diabetes.(3) Mathew Dobson L-1775 A.D : Found that sweetness of urine is due to sugar.(4) Thomas Cowley -1781 AD : Pancreas as the possible cause of the disease.(5) Paul Langerhans -1869 AD : Group of cells in Pancreas.(6) Gusteve Edward -1893 AD : Group of cells as Islets of Langerhans.(7) Opie -1901 AD : Hypothesis- Islets Of Langerhans dysfunction.(8) Babting and Charles -1922 AD : Discovered Insulin. -8- 
  • 22. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) NIRUKTHI AND PARIBHASHA In Ayurveda, Madhumeha is a term used for all the 20 types of Prameha andalso as a sub type of Vatika Prameha which is Asadya. In this present study sinceMadhumeha is taken in terms of Meha Samuha but not restricted to the terms ofVatika Prameha hence understanding its literal Derivation is quite important forproper understanding of the intricacies in the usage of the term Madhumeha1.ETYMOLOGY:Meha: The word Meha is derived from the root ‘Mih Sechane’ by adding lyu’Pratyaya to it, gives the meaning watering. - Shabda Kalpadruma. Mehayati Sinchati Mutraretamsi iti mehaha - Halayudha Kosha Mehayati mutrayati iti arthaha - Su. Ni. 9/10This term is suppose to be used for all types of Meha either it is Prameha orMadhumeha- according to Acharya Chakrapani. The first and the foremost Vedic reference for the word Meha is found in theYakshma Nashana Suktha – 5th Verse, 163rd Suktha of 10th Mandala of Rigveda.Shayana Bhashya21 interpretes the word Mehana as Medr, which means Shishnya i.e.Penis on the above mentioned reference. 1. Prameha1 - The word Prameha is composed of two sub-words. i.e. Pra + MehaAccording to the the above verses, it means to excrete urine and semen profusely. In Sanskrit literatures, the word Mih is used to denote - to make water, to wet,to ejaculate semen. When the prefix “Pra” is added to the root word Mih, the wordbecomes Prameha. ‘Pra’ suggests excess or profuse in both Frequency and Quantity. -9- 
  • 23. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)So, the word Prameha can be understood as increase in both frequency and quantity ofurine. “Prakarshena Mehayati Yasmin Roge” - Su. Ni. 6/10 This derivation of word is again substantiated with the Common ClinicalFeatures of Prameha described as Prabhutamutrata and Avilamutrata. Su.ni.6/6,A.Hr.ni.10/7. 2. Madhumeha: - The word Madhumeha is derived from two words Madhu and Meha. The word Madhu is derived from the root “Manyante Viseshena Jananti JanahYasmin”. In Sanskrit literature Madhu word is used with various synonyms in variouscontexts like Kshaudram, Kusumasavam, Madhyama, Makarandah, Makshikam,Madhura Rasa, Jalam, Pushparasa, Kshiram etc - ArunaduttaSo, Madhumeha is a disease in which the excretion of urine possesses the qualitysimilar to that of Madhu (honey) in its colour, taste, smell and consistency. -Madhavakara. It means ‘Madhumeha’ is a disease in which a patient passes sweet urine andexhibits sweetness all over the body i.e in sweat, mucus, breath and blood etc.PARIBHASHA OF MADHUMEHA: With the above literary background for the term “Madhumeha”, it can bedefined as a clinical entity in which subject passes large quantity of urine withKashaya, Madhura rasa and Ruksha quality similar to the characteristics of honey andthus body attains sweetness – Acharaya Charaka and Vagbhata. -10- 
  • 24. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Acharya Sushruta has narrated the term “Kshaudrameha” in place ofMadhumeha .The “Kshaudra” is one of the varieties of Madhu which is Kapila(tawny) in colour and hence considered as a synonym to the word Madhu as well. So,it is clear that Kshaudrameha resembles Madhumeha. As per Sushruta all the varietiesof Prameha; if neglected, get transformed into the pathological streak of Madhumeha.SYNONYMS: Few of the synonyms of Madhumeha mentioned in the ancient classics arefollows: OJOMEHA: This is one among the four sub-types of Vataja Prameha.Vitiated Vata dosha causes diminution of Ojas through which, the urine along withthe change in its taste and texture finally results in Ojomeha. KSHAUDRAMEHA: This term has been used by Sushruta because of itsclose resemblance with Madhu – Acharya Sushruta. PAUSHPAMEHA: In Anjana Nidana, the word Paushpameha has been usedin place of Madhumeha. In Sanskrit literature, Paushpameha means Madhu.ETYMOLOGY OF DIABETES MELLITUSThe word diabetes is originated from the French word named “Jiyabatis” whichmeans punctured pitcher or pitcher with leak, so that water sprinkles out of it.Diabetes– Parashuram Shastry.The word diabtes mellitus contains two words i.e diabetes and mellitus. In GreekDiabetes means to run through a siphon and the term Mellitus means honey.WHO APPROVED DEFINITION OF DIABETES MELLITUS: -11- 
  • 25. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Diabetes Mellitus is a group of metabolic disorders characterized by chronichyperglycemia associated with disturbances of carbohydrates, fat and proteinmetabolism due to absolute or relative deficiency in insulin secretion and /or action23.SYNROME X or METABOLIC SYNDROME is a cluster of cardiovascular riskfactors that frequently coincides with insulin resistance and hyperglycemia. Themetabolic syndrome is a common condition, associated with genetic predisposition,sedentary lifestyle, obesity, and aging23. -12- 
  • 26. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) NIDANA Nidana is the specific core pre-disposing factor of a disease. The cycle ofpathology and severity of the disease considerably revolves around the type andseverity of the predisposing factors in relation to the tridosha respectively. Ayurvedic classics elaborately describes about the general etiological factorsof Prameha at the same time it is the highness of discretion elucidated by AcharyaCharaka in relation to this disease which even though is Tridosha in origin but it isinfluenced by specific doshic etiologies which inturn decides the extent and strengthof the corresponding disease pathology leading to Madhumeha latter –Vikara VighataBhava Abhava Prativishesha. Hence, classical etiologies mentioned for Prameha canbe taken for Madhumeha also. Etiological factors of Prameha can be classified intoSahaja and Apathyanimittaja. I. Sahaja Prameha: Sahaja Prameha is further divided in to Kulaja and Garbhaja. A. Kulaja Prameha:It is due to defects in Stri & Pumbeeja (Ovum & Sperm) which is said to be Matru-Pitrukrita Beejadosha finally resulting in Sahaja Prameha. This Beeja Doshahighlights the relevance of Kulanupatini Prakruti and may have its origin from parentsof both father and mother i.e. it may be inherited from generation to generation andthus it is a unique example of hereditary disease. B. Garbhaja Prameha: Acharya Charaka opines that indiscrete excessive indulgence of Madhura Rasaby garbhini is the chief cause for the changes and damages in the foetus. Overindulgence in Madhura Rasa by mother during pregnancy is likely to induce Prameha. -13- 
  • 27. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Regarding Sahaja Prameha, genetic predisposition occurring in diabetes hasbeen well established based on various genome studies in conventional science. Studyfocus is mainly on β-cells of islets of langerhans and the blood vessels.Simultaneously, the metabolic functions leading to the rapid conversion of glucoseinto fatty acid forming the adipose tissue have been suspected to have genetic origin.These variations are due to variation of structure and function of chromosomes. Evenafter having genetic predisposition; the stage of overt diabetes may take time toprecipitate – highlighting the concept of Lakshya Nimita1. Hypothetically, indiscrete excessive intake of Madhura Rasa bring aboutchanges at the level of gene and thus provide a genetic pre-disposing condition in thesubject and again intake of excessive Madhura Rasa by the pre-diabetic subject in hisearly life also precipitates Prameha. Thus; Beeja Dosha and Apathya, both play acombined role in the causation of Sahaja Prameha. II. Apathyanimittaja Prameha: Various opinions regarding the discription of Apathyanimittaja Prameha by different Acharyas are described as follows,Charakoktha Apathyanimittaja Prameha Nidana:Asyasukham: Sedentory Sexual Habits and Sedentary Sitting Habits.Swapnasukham: Sedentary sleeping habits.Excessive indulgence in Dadhini: Curd and its various preparations.Gramya, Audaka, Anupa Mamsa: Meat of domestic, aquatic, wet land animals.Payamsi: Excessive use of milk and its preparationsNava Annapanam: Excessive use of new grains and drinks.Guda Vaikrutam: Jaggery and its various preparations. Along with the above etiological factors, all regimens which vitiate Kaphadosha should also be considered as the cause for Prameha. -14- 
  • 28. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Dravya Properties Dosha PrabhavaKoolachara (living at river Madhura Rasa & Vipaka Mutrala & Kaphaside) Eg. Gaja, Gavaya, etc. Sheeta Veerya, Snigdha Guna VardhakPlava (Birds which swim) Sheeta Veerya, Snigdha Mutrala & Kapha Guna,Eg. Hamsa, Kroucha etc. Vardhaka Madhura Rasa and vipakaKoshastha (Live in burrows) Madhura Rasa & Vipaka, Kapha VardhakaEg. Shanka, Shukti etc. Sheeta Veerya Snigdha GunaPadina (which have limbs) Balya MutralaEg. Koorma etc.Matsya Nadeya Madhura Rasa, Snigdha and Shleshma(Fishes of river) Guru GunaSamudra (Fishes of sea) Guru, Snigdha, Ushna, guna, Shleshma Madhura Rasa, and VipakaEg. Timingala, Kulisha etc. CHART: GRAMYA, OUDAKA AND ANUPA MAMSA RASASushrutoktha Apathyanimittaja Prameha Nidana: Acharya Sushruta opines in terms of Snigdha (unctuous), Medya (fatty) andDrava (liquid) type of food as the causative factors.Vagbhatoktha Apathyanimittaja Prameha Nidana: Acharya Vagbhata opines in terms of Madhura, Amla, Lavana Rasapredominant diet and sedentary habits which increase Medas, Mutra and Kapha as thecausative factors.DOSHANUSAARA NIDANA VISHESHA:Kaphaja Prameha Nidana The following are the etiological factors which help in the immediatemanifestation of Prameha due to Kapha dosha - Frequent and excessive intake offresh corns like Hayanaka, Yavaka, Chinaka, Uddalaka, Naishadha, Itkata, -15- 
  • 29. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Mukundaka, Mahavrihi, Pramodaka and Sugandhaka; Intake of Pulses like freshHarenu and Masha with ghee; Intake of the meat of domestic, marshy and aquaticanimals; Intake of vegetables, Tila, Palala, Pishtanna, Payasa (a type of sweetpreparation), Krishara, Vilepi and preparations of sugarcane; Intake of milk, freshwine, Immature curd and its preparations; Avoidance of unction and physicalexercise; Resorting to inappropriate sleeping habit and sedentary habits; Resorting tosuch regimens which produce more of Kapha, fat and urine.Pittaja Prameha Nidana Intake of Ushna, Amla, Lavana, Kshara and Katura Dravyas; Intake of foodbefore the digestion of the previous meal; Exposure to excessively hot sun, heat ofthe fire, physical exertion and anger; Intake of mutually contradictory food articles.Vataja Prameha Nidana Excessive intake of Dravyas having predominantly Kashaya, Katu, Tikta Rasa,Ruksha, Laghu and Sheeta Veerya; Excessive indulgence in sex and physicalexercise; Excessive administration of Vamana, Virechana, Asthapana andShirovirechana; Resorting to suppression of the manifested urges, fasting, assault,exposure to sun, anxiety, grief, excessive blood letting, keeping awake at night andirregular postures of the body.Specific Etiology of Madhumeha: The person indulging in food substances having Guru, Snigdha qualities andexcessive indulgence of Amla and Lavana Rasa substances and Navannapana,excessive sleep, sitting in a same place for longer duration, avoiding exercises –physical and mental exercises and also not resorting to the Shodhana process at propertime or even resorting to the latter at improper time. -16- 
  • 30. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Acharya Sushruta has narrated that untreated Prameha in its initial stage, getsconverted into Madhumeha and becomes incurable. According to Acharya Vagbhata, the urine of Madhumehi will be simulatingwith that of Madhu. Two type of Vata vitiation has been mentioned, one is due toDhatukshaya and second due to Margavarana. According to Acharya bhela, this disease is of two types based on the specificetiologies like 1) Prakruthi Prabhaavam 2) Narasya SwakruthamEtiopathogenesis according to modern medicine: The etiology of Diabetes mellitus has yet to be understood in spite of theadvances made in the knowledge obtained with respect to various factors associatedwith the causation of Diabetes mellitus. Based on the etiological factors Diabetesmellitus can be classified into two main types namely, 1. Primary or Idiopathic Diabetes: Which is further subclassified intoType I Diabetes or IDDM and Type II Diabetes or NIDDM. 2. Secondary Diabetes Mellitus.Causes for Primary Diabetes Mellitus:A. Genetic Factors:a) Genetic susceptibility in IDDM: IDDM is a heterogenous disorder in wich several factors may play a role.IDDM tends to be a familial disorder and there is a 25-fold increase in the riskamongst the siblings than the general population. Its inheritance is strongly related toHLA loci on chromosome-6. It is seen that HLA B8, B15, B6, B21, BW3, DR3 andDR4 are associated with a higher risk of diabetes. In Indians and Japanese IDDM -17- 
  • 31. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)appears to be associated more with HLABW21 and BW54. Among identical twinsonly 50% shows concordance for IDDM as against 100% for NIDDM.b) Genetic Susceptibility in NIDDM: Role of genetic factors in etiology of NIDDM has been appreciated ever sincethe recognition of the disease, but the pathogenesis is less well understood. Thedisease is not linked to any HLA genes as in Type I Diabetes. Though NIDDM occursin families, modes of inheritance are not known except for the variant termedMaturity Onset Diabetes of the Young (MODY), which is due to three different genemutations. MODY 1 gene is located on the long arm of chromosome 20 and that forMODY 3 is on the long arm of chromosome 12 while that of MODY 2 is due tomutation of glucokinase gene located on the short arm of chromosome 7. It is highlylikely that ordinary NIDDM is polygenic.B.Immunological Factors (Auto immunity): The pathogenesis of Diabetes Mellitus mainly depends on the factors insulinand its source, the β-cells. There is no evidence that Auto-immune mechanisms areinvolved in the manifestation of Type II Diabetes (NIDDM) where as IDDM is aslowly progressive T-cell mediated Auto-Immune disease. Hyperglyceamiaaccompanied by the classical symptom of Diabetes occurs only when 70-90% of β-cells have been destroyed. Islet cell antibodies can be detected before the clinicaldevelopment of type-1 Diabetes and disappear with increasing duration of diabetes.Presently these antibodies are neither used for screening nor for diagnostic purposes,but glutamic acid decarboxylase(GAD) antibodies may have a role in identifying late-onset type-1 Diabetes in middle-aged people(Latent Autoimmune Diabetes in Adults-LADA). -18- 
  • 32. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Although; recent studies reveal that approximately 10% of IDDM patients alsosuffer from other Organo-Specific Autoimmune Disorders like Graves’s disease,Addisions disease, Thyroiditis or Pernicious Anemia, there appears to be a broadspectrum derangement of immunoregulation in these patients. By the time OvertDiabetes develops, most of the insulin producing cells of the pancreas - β-cells will bedestroyed completely or will have disappeared.completely.C. Environmental Factors: The environment insult or factors may be the cause for manifestation ofDiabetes Mellitus. In many cases the environmental factor is believed to be a viralinfection of the beta cell. Epidemiological studies have linked viral infection withIDDM. A viral etiology was originally suggested by seasonal variations in the onsetof the disease and by what appeared to be more than a chance relationship betweenthe appearance of diabetes and preceding episodes of mumps, measles, and congenitalrubella, Coxsackie’s B virus, hepatitis, infectious mononucleosis. The isolation of aCoxsackie’s virus B 4 from pancreas of a previously healthy boy who died after anepisode of Ketoacidosis and induction of diabetes in animals inoculated with isolatedvirus, also suggests a viral etiology. Further the support for viral theory comes fromobservations that about 1/5th individuals with congenital rubella develop IDDM.Viruses may damage the beta cells by direct invasion or by triggering an auto immuneresponse. They may also persist with beta cells and cause long term interference withmetabolic and secretory functions. While viruses do not produce IDDM in all infectedindividuals, it is tempting to speculate that in susceptible individuals these infectiveagents trigger a host of immunological phenomena resulting in beta cell death. Theviral theory should be treated with considerable caution. Serologic studies seeking -19- 
  • 33. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)evidence of recent viral infection in patients with new onset IDDM are in conclusiveat best.D. Diet: Circumstantial evidence supports the proposition that dietary factors may, atleast in certain circumstances, influence the development of Type I Diabetes. It hasbeen suggested that exposure to cow’s milk or milk products early in life predisposesto autoimmune Diabetes. The proposed environmental trigger is Bovine SerumAlbumin, operating through the mechanism of molecular mimicry. In the initial studydiabetic subjects were found to have antibodies to bovine albumin and an antibodysubset specific for a 17 amino acid epitope showed to the strongest association withthe disease. Exposure to cow’s milk in presumed to induce an immune response to 17amino acid fragment in some infants, and cross β cells expressing the P 69 antigen.This hypothesis has not received wide support. Various chemical agents like pentamidine, vacor (rodenticide) and variousNitrosoamines found in smoke and curried meat have been proposed as potentiallydiabetogenic factors.E. Age: It is also one of the important risk factor in manifestation of Type II Diabetes.Type II Diabetes is principally a disease of the middle aged and elderly (>40yrs).Recently age of onset of Type II Diabetes mellitus is decreasing and is seen inchildren and adolescents (i.e. <25 years- MODY) 29F. Obesity: Particularly central obesity and a change to western style are inevitableaccompaniment of modernization and it is one of the leading causes for manifestationof Diabetes Mellitus of Type II variety particularly in India. Obesity probably acts as -20- 
  • 34. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)a Diabetogenic factor (through increasing resistance to the action of insulin) in thosegenetically predisposed to develop Type II Diabetes.G. Life Style: The sedentary life style with diminished physical activity combined withovereating and obesity is associated with development of Type II Diabetes Mellitus.H. Stress: Stress may be a possible link factor for Diabetes either through a direct effecton the Neuro-endocrine system by stimulating the secretion of counter regulatoryhormones and possibly by modulating immune activity or indirectly through the cycleof overeating and subsequent development of obesity that may be associated withstress 25.I. Malnutrition in utero: It is proposed that malnutrition in utero may programme beta cell developmentand metabolic function at a critical period, so predisposing to Type II Diabetes later inlife.Causes for Secondary Diabetes Mellitus:Pancreatic Disease: Acute and Chronic pancreatitis, Post Pancreatectomy, congenital pancreaticaplasia, pancreatic carcinoma, cystic fibrosis and Haemochromotosis are few of theconditions which manifests Secondary Diabetes Mellitus.Hormonal Abnormalities: The hormones such as Growth Hormone, Glucocorticoids, Catecholamines,Thyromine and Glucagon cause impaired Glucose Tolerance or even an overtDiabetes, as they have insulin antagonistic effect. Conditions such as Acromegaly,Cushing’s syndrome, and Phenochromocytoma can cause Diabetes, especially in -21- 
  • 35. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)those persons who are prone. It may also arise due to therapeutic administration ofSteroidal Hormones. Stress hyperglycemia associated with severe burns, acutemyocardial infraction and other life threatening illness, is due to excessive release ofGlucagon and Catecholamines.Drugs and Chemical induced Diabetes: Drugs or Chemicals can either impair insulin action or damage the beta cellscausing decreasing in the insulin secretion. Drugs like pentamidine and vacor are betacytolytic, where as glucocorticoids and nicotinic acid increase the insulin resistance.Insulin Receptor Abnormalities: Rare conditions associated with mutation in the insulin receptor or the postreceptor pathway leads to manifestation of Diabetes mellitus. The individuals haveextreme degrees of insulin resistance and are associated with Acanthosis Nigrican’s,polycystic ovaries and rarely virilization. Leprenchaunism could be fatal and patientsdo not cross the infancy.Genetic Disorders: Many genetic syndromes are associated with Diabetes. Down’s syndrome,Klinefelter’s syndrome, Turner’s syndrome and Wolfram’s syndrome are someimportant ones.Role of Endocrine Glands:Pituitary Gland14: The pituitary hormones can influence the course of DiabetesMellitus. The growth Hormone of pituitary has the diabetogenic power.Administration of hormone leads to hydropic changes in beta cells associated with anearly reversible phase of Diabetes followed later by an irreversible phase withcomplete destruction of beta cells. Diabetes may be associated with Acromegaly. -22- 
  • 36. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Adrenal Gland14: Adrenalectomy will arrest or modify the progress of experimentalDiabetes. The onset of Addisson’s disease has an ameliorating effect on the humanvariety. Adrenal Hyperplasia or tumors may be associated with Diabetes.Gestational Diabetes: Gestational Diabetes is defined as any degree of glucoseintolerance with onset or first recognition during pregnancy. During normalpregnancy, insulin sensitivity is reduced through the action of placental hormones andthis affects the glucose tolerance. The insulin secreting cells of the pancreatic isletsmay be unable to meet this increased demand in women genetically predisposed todevelop Diabetes. Repeated pregnancy may increase the likelihood of developingirreversible Diabetes, particularly in obese women. However the patient should beevaluated after six weeks after delivery and reclassified as either diabetic or nondiabetic.Nidana similarities of modern view with ayurveda: The atiological factors mentioned by modern medicine are also in concordancewith ayurvedic scholars. Both systems agree regarding genetic elements associatedwith DM. According to modern view and ayurvedic view sedentary life habits play animportant role. Both systems deal with Medo Dhatudushti Nidana as a cause for DM. -23- 
  • 37. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Table No: 1 Similarities of Nidana in Modern and Ayurveda MODERN VIEW AYURVEDIC VIEW Genetic susceptibility is identified. One variety of prameha is Sahaja due to Sukra and Artava Dosha. Sedentory life habits are a prime Ayurveda also mentioning the same like cause. Asyasukham, Swapna Sukham etc. Diabetis has been discribed as Charaka also describes Prameha as a complication of Obesity due to insulin Complication of Sthoulya. resistance caused by fat globules. Dietary factors influence development Indiscrete use of Cows milk, Gramya of type1 DM.Some Diabetogenic Mamsa, Anoopa Mamsa are considered factors like bovine serum albumin as major Nidana for Prameha by Charaka. found in cow’s milk, nitrosamines present in smoked and cured meat has been identified. Mental factors like stress have been Acharya Charaka explains as Krodha is a accepted as a principal atiology. predisposing factor for Pitha Prameha and mental strain like Udvega and Soka will cause Vataja Prameha. Environmental factors enhance viral Excessive Vata Pita Prakopa infections and leads to diabetes have environments like Atapa Sevana, Agni been described. Santapa etc have been described. -24- 
  • 38. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) PURVARUPA Purvarupa are the most valuable prodromal signs and symptoms that signal theforth-coming disease. Every disease has its own characteristic Purvarupa and becomemanifested at the stage of Sthanasamshraya and it is one kind of warning signal to thesubject to restrain from those activities which triggers Prameha. As Madhumeha isclassified under the Vatika type of Prameha, Purvarupa of Prameha can be taken asPurvarupa of Madhumeha1. Table No 3. Purvarupa of Madhumeha, according to different Acharyas. Purvarupam Cha17 Su20 A.H27 A.S28 Ma.Ni29Kesheshu Jatilibhava + + - + -Asya Madhurya + - + + +Karapadadaha + + + + +Karapada Suptata + - - - -Mukha Talu KanthaShosha + - + + -Pipasa + + - + +Alasya + - - + -Kaye malam + - - + -Kaya Chhidreshu Upadeha + - - + -Paridaha Angeshu + - - - -Suptata Angeshu + -- - + -Shatpada Pipilika + - + + -MutrabhisaranamMutre Cha Mutra Dosham + - - - -Visra Sharir Gandha + + + + -Sarvakala Nidra + - - + -Sarvakala Tandra + + - + -Snigdha Gatrata - + - + -Pichhila & Guru Gatrata - + - - -Madhur Mutrata - + - - -Shukla Mutrata - + - + - ­25­ 
  • 39. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Sada - + - + -Shwasa - + - + -Keshanakhativriddhi + + + - -Sheeta Priyata + - + + -Hridaya Netra Jihwa - - + - -ShravanopdehaSweda + - + + -Dehe Chikkanata - - - - + The manifestation of the above mentioned prodromonal symptoms can beunderstood in co-relation to the stage of Sthanasamshraya where the already vitiatedand dislodged bodily principles starts to find its substratum vide srotas and itsappendages for the development of further pathogenesis within the latter and finallyenabling the process of Atura Samvedhya and Vaidya Samvedhya Lakshanas whichinturn helps the physician to assess the srotas and its appendages afflicted and plan forappropriate therapeutic measures based on the Dushyadi Sameekshya Bhava9.Unexplained fatigue and weight loss has been clinically considered as prodromalsymptoms by modern physicians29. It is in the nature of this disease; Madhumeha, which withholds the globalsystemic illness within its claws that these above mentioned prodromal symptomsthemselves extend to become the cardinal clinical features of the disease. So for theearly diagnosis of this disease – Madhumeha, these prodromal symptoms mentionedfor Prameha - Madhumeha play a pivotal role in guiding and planning the furthercourse of therapeutic measures with the discretion of the physician based on theVikara Vighata Bhava Abhava Prativishesha1. ­26­ 
  • 40. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) RUPA The manifesting symptom of a disease which bears its characteristic features iscalled Rupa. It represents the Vyakthavastha of Shatkriyakala. Acharya Gayadasaopines that in case of Prameha, Purvarupa will be manifested as Rupa. This type ofmanifestation is termed as Vyadhi Prabhava. According to Sushrutacharya, the person should be diagnosed as Pramehiwhen complete or partial prodromal symptoms of Prameha accompanied byPrabhoota mutrata get manifested.Important Samanya Lakshnas of Prameha w.s.r to the UrineCharacteristics:1) Prabhuta Mutrata (Quantity): It is considered as the cardinal sign of Prameha by all Acharyas. AcharyaGayadasa opines on Su.Ni.6/6 that excess urine quantity is because of liquefaction ofthe Dushyas and their mutual amalgamation. It may be suggested that the Prabhuta Mutrata is more akin to metabolicchanges. The excessive urination helps in the elimination of excessive accumulationof carbohydrate, protein and fat metabolites. The excessive urination is due to animproper metabolism of carbohydrates, proteins and fats resulting in water andelectrolytes imbalance.2) Avila Mutrata (Turbidity): Patient passes urine having hazy consistency. Gayadasa and Dalhana opinethat, the characteristic features of urine are because of the amalgamation betweenMutra, Dosha and Dushya. Avila Mutrata is more akin to urinary pathology. This Avila mutrata i.e.turbidity of urine occurs due to body reaction with the Doshas. This can be due to -27- 
  • 41. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)presence of phosphates, sugar, sperm, acetone, silicates, albumin, chyle, bile pigmentsand salts, blood, pus or casts etc. in the urine. Observed facts contribute to the opinionthat quantity of the urine may remain normal or may be reduced in the later stage ofthis disease which in turn depends upon the habit of liquid intake. So, both thesymptoms have been considered as the Cardinal Clinical Features of this disease byAncient Seers.3) Pichhila Mutrata (Consistency): At the time of diagnosis, Charaka mentioned to consider the etiological factorsalso to assess the involved Dosha after knowing the character of urine like Pichhilathaand Madhurya. Acharaya Sushruta has described two types of Prameha along with theirmanifestations as followsSahaja Pramehi (Krisha-Asthenic)Ruksha (Dry body)Alpashi (Consumes less food)Bhrish Pipasa (Voracious thirst)Parisarpansheelata (Restless, always desires to wander)Apathyanimittaja (Sthula-Obese)Bahuashi (Voracious eater)Snigdha (Unctuous body texture)Shayyasanswapnasheela (Like to sit down & sleep always)Acharya Kashyapa has described the following Rupas for Prameha.(a) Akasmata Mutra Nirgama: Excretes urine suddenly without any intention.(b) Makshika Akranta Mutra: Flies get attracted towards the urine. -28- 
  • 42. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)(c) Shweta and Ghana Mutrata: Passes urine having white colour and of turbid nature.Along with the above he has also narrated symptoms like Gaurava (Heaviness of thebody), Baddhata (tightness) and Jadata (Procrastination).Specific Lakshanas of Madhumeha: (Visesha Rupa)Urine Characteristics: Madhumehi passes urine having Kashaya and Madhura taste, Pandu Varnaand Ruksha quality. Gangadhara opines on this that the Madhura Rasa of Ojas isdisplaced by Kashaya Rasa. Chakrapani opines that Vata, because of its Prabhavaconverts Madhura Ojas into Kashaya Ojas. According to Sushruta, the urine of Madhumehi resembles with that of honey,as described above. Similar description is found in Ashtanga Hridaya and AshtangaSamgrahakara.CLINICAL FEATURES OF DIABETIS MELLITUS:Type I Diabetes Mellitus: Type I Diabetes Mellitus usually begins before age 40 years. This type ofDiabetes is characterized by a rapid onset, with symptoms such as Polydypsia,Polyuria, Polyphagia, weight loss associated with Random Plasma Glucose level ≥200 mg/dl. In the fulminating case, the most striking features are those of salt andwater depletion i.e. loose dry skin, furred tongue, cracked lips, tachycardia, andhypotension and reduced intraoccular pressure. Breathing may be deep and sighingdue to acidosis, the breath is usually fetid and the sickly sweet smell of acetone maybe apparent. Once the symptoms develop, Insulin therapy is required. Occasionally aninitial episode of Ketoacidosis is followed by a symptom free interval (the“honeymoon” period), during which no treatment is required. -29- 
  • 43. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Type II Diabetes Mellitus: Type II Diabetes Mellitus usually begins in middle life or later. The typicalpatient is overweight. Symptoms begin gradually. Candidal vaginitis or Pruritisvulvae29 or balanitis is a common presenting symptom since the external genitalia areespecially prone to infection by fungi (Candida) which flourish on skin and mucousmembranes contaminated by glucose due to varied pH within the vaginal canal.Blurred or decreased vision due to retinopathy is found due to the prothrombotic andplatelet aggregation caused by the endothelial dysfunction. Depression or loss oftendon reflexes at the ankles and impaired perception of vibration sensation distally inthe legs indicate neuropathy caused due to the accumulation of AGEs which areneurotoxic in nature25. Hypertension and signs of atherosclerosis are common andmay include diminished or impalpable pulses in the feet, bruits over the carotid orfemoral arteries and gangrene of the feet. Signs of dehydration with associated alteredconsciousness are recently noted in cases with severe hyperglycemia. Clinical featurescan be classified as follows, TableNo.4 Clinical Features of Diabetes Mellitus29 SYMPTOMS TYPE – I TYPE – II Polyuria and thirst ++ + Weakness or fatigue ++ + Polyphagia with weight loss ++ - Ketoacidosis ++ + Impotency ++ + Nocturnal enuresis ++ - Recurrent blurred vision + ++ Vulvovaginitis /Pruritis Vulvae + ++ Peripheral Neuropathy + ++ Often asymptomatic - ++ -30- 
  • 44. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) We can find more similarities between ayurvedic and modern perception overthe clinical features of Madhumeha vis a vis Diabetes Mellitus like Polyuria -Prabhutamutrata, Polydipsia - Pipasa Adhikata, Polyphagia – Kshudha Adhikataetc. They have been discussed as follows,TableNo.5 Similarities of symptoms in Modern and Ayurvedic views: MODERN VIEW AYURVEDIC VIEW Polyuria Prabhutamutrata Polydipsia Pipasa Adhikata Weakness and fatigue Dourbalya Polyphagia Kshudha Adhikata Glycosuria Avila mutrata - Mutramadhurya Lassitude Alasya Increased turbidity and specific gravity Avilamutrata of urine. -31- 
  • 45. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) SAMPRAPTI Samprapti of a disease can be literally understood as the process of obtainingthe complete purview of a disease by bridging the discipline of basic fundamentalprinciples with the clinical observation by studying the specific patterns of vitiationrelated to the doshas and dushyas underlying a disease due to its variety of Nidanaand its successive sequential events through the mode of Prasara andSthanasamshraya in to various parts or visceras of the body upto the ultimateexpression of the diseased condition and its complications. This indeed due to thetechnological advances has become more exciting scientifically and also gained moreimportance in relation to the selection of medicine especially in our stream ofmedicine – Ayurveda, since all therapeutic modalities are aimed at breaking up thisvicious cycle of pathogenesis -“Samprapti Vighatanameva Chikitsa.” For the manifestation of any disease condition in the body, the important threeinter-connected factors are Nidana, Dosha and Dushya. Likewise; when these threefactors are not well established within the body, then the occurrence of the diseasewill be questionable. The Nidana - Gurvadi, Dosha - Vatadi, and Dushya - Rasadi areresponsible for the manifestation or non-manifestation of the disease. If the Inter-relationship or Paraspara anubandha of the above three factors are of Hina Bala andare not connected to each other; then, the chances of manifestation of the disease willbe of considerably low. If these three factors are having less strength and connectedwith each other then the manifested disease will not have all the signs and symptoms.If they are complete and with full strength and their inter-connection is strong enough;then, the disease occurrence and manifestation can be termed as the Status Ultimatumwith complete clinical manifestation of the disease. However, this in relation to the -32- 
  • 46. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Diabetes Mellitus is termed as Overt Diabetes and possibly can be related to theAsadya state of the disease Madhumeha. Prameha vis a vis Madhumeha is included in the group of diseases which areestablished in the body due to Santarpana. Charaka Acharya has well established thesequential events occuring in the process of establishment of the disease by explainingthe Dosha Dushyadi Samprapthi Ghatakas in detail. For better understanding ofMadhumeha Samprapti it is worthy enough to discuss in detail regarding variouspatterns of Prameha Samprapti since the other facet of this condition Madhumehaincludes as a category of Vatika Prameha. Some important points in this concept are natural Kapha in the PrakrutaAvastha is responsible for the existence of Apara Ojas and its corresponding function.Here in Prameha Samprapti it gets disturbed due to respective preceding etiologicalfactors mentioned for the vitiation of the dosha, particularly Kapha Dosha. The Dushya Sangraha is Meda, Mamsa, Shareera Kleda, Shukra, Shonita,Vasa, Majja, Lasika, Rasa and Ojas. The special characteristic features of theseDushyas are elicited to be Bahvabadha form. Due to Nidana Sevana Kapha Pradhana Tridosha Prakopa occurs and AparaOjas in Bahudrava Kapha form vitiates Shareera Kleda, Meda, and Mamsa etc. Itfurther vitiates to reach the Sthanasamsraya stage within Basti along with the Dushyasand produce Kaphaja Meha. When Kapha Kshaya occurs it will began to vitiate PitaDosha and its Anubandha Dushya. As a result Pitha Kshaya occurs and lastly VataPradhana Dosha Dushti occurs and results in Vataja Prameha. These abovedescriptions are liable for discretion based on Vyapadeshastu Bhuyasa rule. -33- 
  • 47. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) ChartNo.1 SAMPRAPTI OF MADHUMEHA - VARIETY 1 Dushana of Kapha by Nidana Sahaja Prameha Apathya Nimitaja Bahudrava Kapha Dushana of Meda, Kleda, Mamsa etc Bastiprapti of Dosha and Dushya Kapha Prameha Pitha Prameha Vata Prameha The above mentioned pattern is the gradual development of the Madhumehaeither through Avarana or Dhatu Kshaya. In other words the Samprapti of Meha canbe discreted according to the Dushyas involved and the dominating Dosha involved.The possible streak of pathology from Kaphaja Meha to Vatika Meha based on theGati and Pradhanata of Dosha, Dushya Samurchana can be explained as follows in thetable. TableNo.6 Ashraya Ashrayi Bhava9 Dosha Prakopa Dushya Meha produced Kapha Rasa, Mamsa, Meda, Ojas Kaphaja Pitta Rakta Pitaja Vata Remaining Pradhana Dhatus Vataja (Vasa, Majja, Lasika,) -34- 
  • 48. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Samprapti of Kaphaja Prameha: After giving a clear picture of these common factors, Acharya Charaka beginswith the causative factors of Kaphaja Meha. With the specification of some Aharasand Viharas which lead to Kapha Vrudhi, he concludes them by saying that all thosefactors which lead to the Vrudhi of Kapha Meda and Mutra are included in theNidanas of Kaphaja Meha. Due to Nidana Sevana the Kapha Dosha undergoes provocation andMedomamsadi Dushyas are getting vitiated. When these two events occur the KupitaKapha – Apara ojas spreads easily and this spreading of Dosha is supported by OjoVisramsa and Ojo Vyapath Lakshanas. The affinity of Kapha Dosha towards thefactors of same quality plays an important role here. The liable Medo Vikruthi havingSamanya Bhava with Kapha Dosha combines together. Kapha Dosha due to itsvitiated nature vitiates Medo Dushya also. The further course of these combo factors in the body is to vitiate the ShareeraKleda, Mamsa and Vasa due to few Samanya Bhava, this further lead to Vrudhi ofSharira Kleda and Mamsa dushti. Within this stage of Mamsa Dushti, Rakta Dhatuand its appendages gets afflicted due to the varied involvement of vitiated pita doshawhich in combination with the above combo factors are responsible for vitiation ofSveda and Medas in the body successively to create a sufficient amount of MalaSanchaya within the disturbed Koshta. All these together inclines towards theacquisition of Samalatva form of Mutra which is guided towards the correspondingMutravaha Srotas to establish the Samanya Lakshana of this condition.Samprapti of Pitaja Prameha: Basically the Samprapti of Pitaja Meha is same as that of Kaphaja but theNidana which directly provocate Pita Dosha, the latter dosha pita and the affinity -35- 
  • 49. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)towards the respective Dushya Dushti with the predominance of pita dosha andassociated with the kapha and vata dosha in establishing varied degrees of clinicalmanifestation.Samprapti of Vatika Prameha: When an individual who’s Mamsa, Meda, Kleda are already vitiated isexposed to the Nidanas of Vata Dosha Prakopa, it directly lead to Vatika Prameha.The Nidana are those which affect Sharira Bala very much like Ativyayama, improperShodhana Chikitsa, Atiyoga, Shoka, Bhaya etc. This is the condition when VataDosha undergoes provocation. Then the Kupita Vata Dosha attracted towards theremaining important Dushyas like Vasa, Majja, Lasika and Ojas. These vitiatedfactors reach basti and are eliminated in Mutra form.Samprapti of Madhumeha1: Acharya Sushruta opines that if Prameha vis a vis Madhumeha is not treated intime, they gradually pass to Asadya stage of Madhumeha. Acharya Charaka hasdescribed Madhumeha vividly based on the Vikara Vighata Bhava AbhavaPrativishesha principle. Vagbhata divides Madhumeha into two types, according toSamprapti. The Asadya variety of Madhumeha is included in Vataja type. If VataPrakopa occurs due to Sarvadhatukshaya, it is called Dhatukshayajanya Madhumeha.And if Vata prakopa manifests as result of Avarana, it is termed as AvaranajanyaMadhumeha.Different mode of Samprapti of Madhumeha: The pathogenesis of Madhumeha is explained in Charaka Samhita,Nidanasthana 4th chapter. Due to causative factors in the person susceptible forPrameha, Vatakopa occurs. This Kupita Vata Dosha attracts the vital and deep seatedDhatus like Vasa, Majja, Lasika and Oja to Basti. The Vata Dosha is having -36- 
  • 50. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Rukshatva and it again changes the Madhura Rasa of Oja into Kashaya Rasa. ThisKashaya Oja is excreted through urinary tract later. Chart No.2 – SAMPRAPTI OF MADHUMEHA - VARIETY 2a) Madhumeha Due to Kevala Vata: Due to the Kapha and Pita Kshaya, and with the Kshaya of Vasa, Majja,Lasika and Ojas, Vata Dosha gets aggravated and draws Ojas towards basti leading toMadhumeha.b) Dhatukshayajanya Madhumeha: The Kshaya of vital dhatus Vasa, Majja, Lasika and Ojas leads toVataprakopa. This vitiated vata further makes Ksharana of these dhatus throughMutravaha srotas resulting in Vasameha, Majjameha, Hastimeha and Madhumeharespectively. When Kapha and Pita gets depleted Vata gets provocated and it leads todepletion of Dhatus. -37- 
  • 51. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)c) Avaranajanya Madhumeha: Aharas with the predominance of Guru, Snigdha, Amla and otherKaphapitakara Nidana leads to the provocation of Kapha and Pita doshas. This in turnvitiates Medas and Mamsa. These increased dosha-dushya cause avarana dosha bywhich normal gati of Vata Dosha is disturbed. Finally vitiated vata carry thecirculating Ojas towards basti resulting in the Madhumeha condition.d) Apratikarita Madhumeha8: Acharya Sushruta has described that all types of Prameha - Madhumeha, if nottreated in time, gets converted into Madhumeha. This is the later stage of disease.SAMPRAPTI GHATAKAS:a) Dosha: All the three doshas are responsible in producing Prameha- Madhumeha,based on Vyapadeshastu Bhuyasa rule - Kapha, Pita and Vata respectively.(i) Kapha: A. Bahu and Abadha in Avaranjanya Madhumeha B. Kshina in Dhatukshayajanya Madhumeha Kapha Dosha- Apara Ojas has the status as dominant dosha in either type ofSamprapti. The first vitiated dosha is kapha - . Acharya Charaka while describing theNidana has used the term ‘Kaphakrut cha sarvam’. It indicates the importance ofKapha Dosha Dushti and the subsequent Ojas disturbance in Meha. Ojo VyapatLakshanas are well appreciated clinically.(ii) Pita: A. Vrudha-in Avaranjanya Madhumeha B. Kshina- in Dhatukshayajanya Madhumeha -38- 
  • 52. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Status of Pita Dosha is Vrudha in Avaranjanya Madhumeha. In this state dueto respective Nidana, Vrudhi Lakshanas will be manifested. In DhatukshayajanyaMadhumeha, Vata dosha is in the Kupitha state, So lakshanas related to Pita DoshaVikruthi and Vata Dosha are quite evident clinically. Kshudha Adhikata, Atisweda etc. like Pita Vrudhi lakshanas are evident inAvaranajanya Madhumeha and Mandagni, Prabhahani etc. like Pita Kshaya lakshanasare found in Dhatukshayajanya Madhumeha.(iii) Vata: A. Avruta- in Avaranjanya Madhumeha B. Vrudha-in Dhatukshayajanya Madhumeha It possesses Gati and Yogavahi Svabhava. In Madhumeha the provocation ofthis dosha occurs in two ways i.e. Margavarodha and Dhatukshaya .This vitiateddosha then carries the vital dhatus like Vasa, Majja, Lasika and Oja to basti andresults Madhumeha.Role of Vyana and Apana: In Su.Ni.1/20, it is described that Vyana and Apana are the main culprits inPrameha- Madhumeha. Vyana being pervaded all over the body and Apana inVankshana, Vyana acts as the collector of Kleda and Apana as Excretor. Theprovoked vata carries the dushyas like Vasa, Majja and Ojas towards Basti andexcretes through urine. Again the excretion of dushyas exaggerates vata provocationand hence the vicious cycle goes on.b) Dushyas: Nidana, Dosha and Dushyas are the three factors responsible for themanifestation of every disease. But when they are having Anukulatva diseaseestablishes in its way. So Anukulatva of these factors is important in Madhumeha. -39- 
  • 53. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)The ten Dushyas described in Madhumeha are Rasa, Rakta, Mamsa, Meda, Majja,Vasa, Lasika, Oja, Shukra and Ambu38. Vagbhata Acharya includes Sveda asadditional.39 Citation - Charakasamhita Chikitsasthana, Kleda has been referred to asAmbu. Acharya Sushruta also have considered the above factors. Meda is common dushya in all Prameha Samprapti. While considering thePurvarupa at the Sthanasamshraya level, Keshanakhati Vrudhi mentioned refers to themala as a result of Asthi Dhatu. Thus almost all the dhatus are involved in this diseasewhich leads to either Asadhyatva or Krichrasadhyatva.Rasa: Rasa is the seat of Kapha Dosha. At the same time, the Prakupita Avasta isconsidered as mala of Rasadhatu. So vitiation of Kapha is the result of vitiation ofRasadhatu. The symptoms like Alasya, Gaurava and Karshya are produced as a result.Rakta: Mainly connected dushya in Pitaja Meha Samprapti. The symptoms and signsdue to its involvement are Daha, Pidaka, and Vidradhi etc.Mamsa: It is a seat of Kapha Dosha. The vitiated Meda combines with it and resultsin Putimamsa pidakas.Meda: It is the dominant dushya in all types of Pramehas. Both quantitatively andqualitatively it is vitiated. Abadhatva is qualitative and Bahutwa is quantitativevitiation. Shareera Shaithilya is produced by Abadha Meda and Bahutwa of Medaleads to Dhatwagnimandya. Dhatwagnimandya leads to Medo Vrudhi in turn.Majja: In the Samprapti of Madhumeha, Majja gets depleted as a result ofVataprakopa. The provoked vata draws Majja towards Basti and excretes throughMutravaha srotas leading to Majjameha which signifies the highest degree ofvitiation. -40- 
  • 54. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Shukra: Shukra is having an important role in Sahaja Prameha. Prameha is a KulajaVikara and occurs as result of Beeja dosha. Vyana and Apana are the causative factorsfor Shukra dosha and Prameha. Vata causes depletion of Shukra Dhatu and causesShukra Meha.Ojas: Apara Oja is the one disturbed initially which later in Vataja type of Pramehavis a vis Madhumeha alters its quality and carries towards basti and excretes throughurine. The manifestations like Gurugatrata, Nidra, and Tandra are the result of OjaVisramsa and Vyapat which finally at the highest degree of vitiation draws the ParaOjas to cause death.Kleda: Kleda itself is an important dushya in Prameha. It makes other dushyassusceptible for the progression of the Samprapti. Kleda promotes analogy betweenDosha and Dushya. The increased Kleda with Bahudrava Sleshma and BahvabadhaMeda amalgamates with vitiated Doshas and Dushyas resulting in increased amountand frequency of the urine along with adding Samalatva to it thus altering itsturbidity, specific gravity and transparency.Vasa: Vasa, the Upadhatu of Mamsa has been described as the predominant dushyaaffected in Vataja Prameha. Vasameha is one type of Vataja Prameha which signifiesthe highest degree of vitiation.Lasika: Lasika is one type of body fluid described as - its dushti will be predominantin Hastimeha.Sweda: Sweda has been described as dushya by Acharya Vagbhata. Atisweda andVisra shareergandha occurs as a result of Sveda dushti along with other dushyas.(c) Srotas: (Medovaha, Mutravaha, Udakavaha) Mutravaha srotas is mainly involved in this disease. Medovaha, MamsavahaSrotodushti also occurs in Madhumeha. Prabhuta Avila mutrata is a result of -41- 
  • 55. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Mutravaha Srotodushti. Purvarupa of Prameha mentioned like, Kaye Malam, SnigdhaGatrata, and Pichila Gatrata is the manifestations of Medovaha Srotodushti.Udakavaha Srotodushti produces symptoms like Pipasa Adhikata, Mukha-Talu-KantaShosha. Sharavika, Kachapika etc. like pidakas gets manifested when MamsavahaSrotodushti occurs.d) Role of Agni and Ama: Madhumeha is a metabolic disorder which is the result of Dhatwagnimandya.In Ayurvedic concept Pachana tatvas are Jataragni, Bhutagni and Dhatvagni. Whentaken food materials are properly digested it can be absorbed for further building upof the body. Otherwise a non absorbable form is produced after semi digested stage.This concept is applicable not only to the food ingested by the individual but also canbe applied to the cellular level. The food which is in the semidigested form is notcapable of entering to the Srotomukhas due to pichila, Guru Guna and can be termedas Ama. In the case of Dhatvagni it helps in the Parinama of dhatus from rasa toshukra. When it loses its potency or when it is less, it leads to Dhatuvrudhi and viceversa. Due to specific nidanas, Agnimandya occurs and it further leads to BahudravaKapha and Bahvabadha Meda. Kleda and mamsa also increases within the same stage. The concept of Agnimandya is the same in case of Avaranjanya Madhumehaalso. Agnimandya occurs in a same way and it leads to the improper digestion ofexcessive dhatus and is not assimilated properly leading to the vitiation of the specificDhatu. This vitiated dhatu obstructs gati of vata. Due to Kupita vata, Jataragniincreases and it requires more and more food. This further leads to the tendency totake more food which in turn leads to Medovrudhi- impaired lipid and proteinmetabolism. Samprapti Ghatakas had been summarized as follows. -42- 
  • 56. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Dosha : Kapha Arambhaka TridoshajaDushya: Meda, Mamsa, Shareera Kleda, Shukra, Lasika, Vasa, Majja, Rasa, Raktaand Ojas1.Mala: Sveda, Mutra, Kesha, Nakha.Agni: Jataragni, DhatvagniAma: As the Mandagni leads to formation of Aparipakva Ahara rasa.Srotas: Medovaha, Svedovaha, Rasavaha, Raktavaha, Annavaha, Mutravaha andUdakavaha.Srothodushti: Sanga and Atipravruti.Udbhavasthana: Amasaya.Adhishtana: Vapavahana and Vrukkas.Sanchara Sthana: Mutravaha SamsthanaVyaktha Sthana: Basti.Vyadhi Svabhava: Chirakari, Anushangi.Rogamarga: Bahya Rogamarga as Rasa, Rakta and Mamsa dhatus are involved.Abhyantara Rogamarga is also involved in the disease as Koshtangas like Amasaya, ,Pakvashaya, Vrukka etc. are affected – signifying the Global Systemic Affliction. SAMKHYA SAMPRAPTI OF PRAMEHA (CLASSIFICATION) Classification of a disease is mainly done for the purpose of properunderstanding of the disease and to formulate an effective treatment protocol. In thispoint of view various types of classification of Prameha including Madhumeha hasbeen described by the ancient Ayurvedic scholars. This has been elaborated asfollows. -43- 
  • 57. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)1. Classification based on Nidana (Etiology) 17, 18, 19.The root cause of disease has enough importance for the prognosis and treatment ofthe disease. The occurrence of Madhumeha according to this point of view is of twotypes. A) Sahaja [Heriditary] B) Apathyanimittaja [Acquired]A) Sahaja Sahaja Prameha occurs as a result of Beejadosha i.e. genetic origin16.While describing prognosis, Acharya Charaka has narrated that Prameha orMadhumeha occurring due to Beeja dosha is incurable.B) Apathyanimittaja Apathyanimittaja type itself suggests its etiology. It occurs due to Ahitahara17.On analyzing the Samprapti, Apathyanimittaja Madhumeha is of two types. a) Santarpanjanya: Santarpanjanya Madhumeha which is directly due to intake of nutritious diet, which are having Kaphavardhaka properties. The excess intake of such substances will primarily lead to the vitiation of Kapha, Pita, Meda and Mamsa, which in turn cause Madhumeha by doing avarana of vata.43 b) Apatarpanjanya: If the substances which deplete the dhatu and aggravate vata are consumed then it leads to Apatarpanjanya Prameha. They act through vitiation of vata which in turn leads to the manifestation of Madhumeha.2. Dosha [Clinicopathological classification]: Twenty types of Prameha have been described by the different authors ofAyurvedic Classics. Among these, 10 are of Kaphaja type, 6 are of Pitaja type and 4belong to Vataja type. They are enlisted below, -44- 
  • 58. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) TableNo.7 – Dosha classification of Prameha- Different views Types Charaka44 Sushruta45 Vagbhatta46 Madhava47 Kaphaja Meha Udakameha + + + + Ikshuvalikameha + + Ikshumeha Ikshumeha Sandrameha + + + +Sandraprasadameha + Surameha Surameha Surameha Shuklameha + Pishtameha Pishtameha Pishtameha Shitameha + Lavanameha + + Sikatameha + + + + Shanairmeha + + + + Alalmeha + Phenameha Lalameha Lalameha Shukrameha + + + + Pitaja Meha Ksharameha + + + + Kalameha + Amlameha + + Nilmeha + + + + Lohitameha + Shonitameha Raktameha Raktameha Manjishtameha + + + + Haridrameha + + + + Vataja Meha Vasameha + + + + Majjameha + Sarpimeha + + Hastimeha + + + + Madhumeha + Kshoudrameha + + -45- 
  • 59. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)3. Classification based on Samprapti: According to mode of Samprapti Pramehaespecially Madhumeha can be classified in to two.a) AvaranjanyaMadhumeha48In Avaranjanya Madhumeha, Kaphavardhaka Nidanasevana leads to vata avarana,which in turn leads to Ojas Karshana which comes to the basti and patient passesMadhura, Kashaya, and Ruksha Mutra, which is said to be Madhumeha.b) DhatukshayajanyaMadhumeha49Whereas in Dhatukshayajanya Madhumeha, due to Vatavardhaka nidana,Vataprakopa occurs and the Madhuratva of Oja is displaced by Kashaya rasa and it isbrought to the basti leading to Madhuvat Mutratyaga, leading to Madhumeha. 504. Prognostic Classification: Prognosis is an inevitable part of Chikitsa so far as a wise physician isconcerned. Success of treatment depends on an unbiased prognosis. On the basis ofthe prognosis we can classify Prameha as follows. TableNo.8 Sadhya Asadhyata Sadhya Yapya Asadhya Kaphaja Pitaja Vataja Sthula (Obese) Usually not much obese Krusha (Asthenic) Apathyanimittaja (Acquired) Acquired Sahaja (Heriditary) Early Stage Acute Stage Advanced Stage Without complication With Complication with Complication -46- 
  • 60. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)5. Classification of Prameha- based on physique51 Clinicopathological status of a disease has an invariable relation with physicalconstitution of the body in Madhumeha. This has to be taken into consideration whentreatment is formulated. According to this, in Ayurveda, Madhumeha is of two types. a) Sthula b) KrushaPATHOGENESIS OF DIABETESMELLITUS 52Pathogenesis of type 1 Diabetes Mellitus This type of Diabetes results from autoimmune destruction of β cell. Threeinterlocking mechanisms are responsible for the islet cell destruction. Geneticsusceptibility, autoimmunity and an environment insult. Genetic susceptibility islinked to specific alleles of the class II major histocompatability complex and othergenetic loci that predispose certain persons to the development of autoimmunityagainst β-cell cells of islets. The autoimmune reaction may develop spontaneously oris enhanced by an environment event like viral infections that alters β-cell cells,rendering them immunogenic. Overt diabetes developed appears after most of the β-cell cells have been destroyed.Pathogenesis of type 2 Diabetes Mellitus There are two main metabolic defects responsible for this type of diabetes.One is the derangement in the β cell secretion of insulin and the other one is theinability of peripheral tissues to respond to insulin (insulin resistance).Epidemiological studies indicate that type-2 diabetes results from a collection ofmultiple genetic defects. -47- 
  • 61. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Derangement in β-cell secretion of insulin This condition is primarily due to degeneration of β-cells by numerousmechanisms. One major reason is excess formation of uncoupling protein2 (UCP2)inside the β-cell cell from a defective mitochondrial pathology which may be fatal tothe β-cells. Another mechanism is the deposition of Amyloid protein inside thepancreatic islets. Amyloid is toxic to β-cells and may thus contribute to the β-celldestruction. a) Insulin resistance There are three main targets of insulin action-adipose tissue, muscles,and liver. In both pregnancy and obesity insulin sensitivity of target tissues willdecreases. These failures of utilization of insulin by peripheral tissues are calledinsulin resistance. As a result the blood glucose level will be elevated. The relationbetween obesity and insulin resistance has been ruled out. Recent studies indicate thatadipose tissue is not merely storage site for triglycerides, but is a versatile endocrinetissue that can carry out a dialogue with muscle and liver both important targets ofinsulin. The adipose tissue secretes 4 important secretions which are having profoundeffect on insulin. They are Leptin, Resistin, tumour necrosing factor (TNF), and freefatty acids. Increased Leptin will decrease obesity and insulin resistance where as allthe other three will promote obesity and insulin resistance. Adequate amount ofAdiponectin – a potent insulin sensitizer is the counter protein within the liverresponsible for reducing insulin resistance and increasing insulin sensitivity. 53Modern classification According to etiological factors:A) Type 1 Diabetes mellitusB) Type 2 Diabetes mellitus -48- 
  • 62. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)C) Other Specific types 1. Genetic defects of β-cell function 2. Genetic defects in Insulin actionD) Diseases of the exocrine pancreas 1. Pancreatitis 2. Trauma 3. Neoplasia 4. Cystic fibrosis 5. OthersE) Endocrinopathies:F) Drug or chemical induced 1. Glucocorticoids 2. Thyroid hormone 3. ThiazidesG) Infection 1. Congenital rubella 2. Cytomegalovirus 3. OthersH) Uncommon forms of immune mediated DiabetesI) Other genetic syndromes 1. Down syndrome 2. Klinfelter’s syndrome 3. Turner’s syndrome 4. Wolfram syndrome 5. Myotonic dystrophy -49- 
  • 63. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) 6. Prader – Willi syndrome 7. Friedereich’s ataxia 8. Huntington’s chorea 9. OthersJ) Gestational Diabetes MellitusK) Others 1. Acromegaly. 2. Cushing’s syndrome. 3. Pheochromocytoma 4. Hyperthyroidism 5. Others. -50- 
  • 64. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) SAPEKSHA NIDANA Acharya Charaka describes that when Madhumeha is present, sometimes it isdifficult to distinguish it from Kaphaja meha because Mutra in Madhumeha is withMadhura taste and having Pichila Svabhava and appearance like honey. So AcharyaCharaka instructs to consider the presence of Rupa and Nidanas. If there aresymptoms of Dosha Kshaya (Kapha-Pitadi Kshaya in comparison to Vata), then it isVatika Prameha and if there is history of Santarpanjanya nidana, then it isKaphasambhava Prameha. This is important because if Madhumeha Rogi is havingless strength due to Dhatukshaya and Vatakopa is treated with Kaphamehopakramaswhich will be responsible for producing adverse results.70 at the same time this can beunderstood well with discretion based on the Vikara Vighata Bhava AbhavaPrativishesha principle. A protocol for differential diagnosis is given below. TableNo.9 Differential Diagnosis Sl Madhumeha Ikshuvalikameham21 Shitameham21 No. 1 Vataja Kaphaja Kaphaja 2 Patients may be Krusha Patients are Sthula Patients are often or Sthula Sthula 3 Symptoms of Oja kshaya No Oja kshaya No Oja kshaya 4 Incurable or Yapya Curable Curable 5 Avilamootrata Avilamootrata Avilamootrata is absent 6 Chronic Acute Acute 7 Shareera and Mutra Mutra Madhurya only Mutra Madhurya Madhurya onlyFrom the conventional medicine point of view it is considered that all the secondarycauses for Diabetes Mellitus and also secondary causes for temporory hyperglycemic -51- 
  • 65. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)state should be considered along with few recent diagnostically productive laboratorywork ups like Serum Fructosamine test and Glycosalated hemoglobin test for a betterEvidenced Based Prognostic Approach. The most important factor to be evaluatedalong with these above mentioned factors is the quality of life which is highlyresponsible for providing a better picture of the disease state and its prognosis withthe administered medications and lifestyle modifications32. -52- 
  • 66. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) UPADRAVA The term upadrava is applied to a disease which has taken place on, producedby the sampraptighatakas of original disease and be cured if original disease is treatedsuccessfully. Acharaya Charaka enumerated the general complications whereas AchrayaSushruta and Acharya Vagbhatta described according to the Dosha predominance.(1) General Complications54 Trishna, Atisara, Daha, Daurbalya, Arochaka, Avipaka, Putimamsa, Pidaka,Alaji, Vidradhi etc.(2) Specific Complications:(a) Kaphaja meha55 Makshikopasarpanam, Alasya, Mamsopachaya, Pratishyaya, Shaithilya,Arochaka, avipaka, Kaphapraseka, Chhardi, Nidra, Kasa and Shwasa are said to becomplications of Kaphaja meha.(b) Pittaja meha56 Vrushanayoravadaranam, Bastibheda, Medhra toda, Hridshula, Amlika, Jwara,Atisara, Arochaka, Vamathu, Paridhumayanam, Daha, Murchha, Pipasa, Nidranasha,Panduroga, Pitavinmutranetratva and Vidbheda (A.H.) are said to be the complicationof pittaja meha.(c) Vataja meha57 Hridgraha, Laulya, Anidra, Stambha, Kampa, Shula, Baddha purishatva andshosha, kasa, shwasa are said to be the complication of vataja meha. ‐ 53- 
  • 67. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Complications of Madhumeha: Acharaya Charaka has mentioned 7 types of pidakaas complication of madhumeha, while Sushruta and Vagbhatta have mentioned 10pidakas. Sushruta has mentioned that madhumeha along with pidaka is asadhya. Henarrated that these pidaka occurs due to Tridosha and vitiated meda and mamsa. Table No.9 Prameha PidakaPidaka Charaka58 Sushruta59 Vagbhatta60Sharavika + + +Kacchhapika + + +Jalini + + +Sarshapi + + +Alaji + + +Vinata + + +Vidradhi + + +Putrini - + +Masurika - + +Vidarika - + +COMPLICATIONS OF DIABETES MELLITUS61 Complications of Diabetes mellitus fall into two major divisions i.e. AcuteComplications and Chronic Complications. The complications resulting from thedisease are associated with the damage or failure of various organs such as the eyes,kidneys and nerves.Acute Complications Diabetic Ketoacidosis and Non Ketoic hyperosmolar state are the acutecomplication.Chronic Complications:(1) Macrovascular Complications: Coronary artery disease. Peripheral Vascular disease. ‐ 54- 
  • 68. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Cerebro vascular disease.(2) Microvascualar Complications: • Diabetic Eye disease Retinopathy (non-proliferative/proliferative) Macular edema Glaucoma Cataracts • Diabetic Neuropathy Poly neuropathy /mono neuropathy Autonomic neuropathy.(3) Other Gastro intestinal [gastroparesis, diarrhoea] Genito urinary [uropathy /sexual dysfunction] Dermatologic infections. Diabetic foot.(A) Acute Complications: Diabetic Ketoacidosis [DKA]: Ketoacidosis is one of the most serious metabolic complications of diabetes,even if managed properly. It can be developed for individuals with type1 DM.Theprognosis substantially worsened at the extremes of age and in the presence of comaand hypotension.Clinical Features: Nausea, vomiting, thirst, polyuria, abdominal pain, altered mental function arethe clinical features of DKA.Physical Findings: Tachycardia, Dry mucous membranes, reduced skin turgor, Dehydration,hypotension, Tachypnea, Kussmaul respirations, respiratory distress, abdominal ‐ 55- 
  • 69. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)tenderness, Fever, Lethargy, Obtundation, Cerebral edema and possibly coma are thephysical findings of DKA.Precipitating Factors: Infection, Cerebrovascular Accident, Myocardial infarction, Alcohol abuseand discontinuation of or inadequate insulin is the main precipitating factors for DKA.Treatment: Correction of dehydration, hyperglycemia and electrolyte imbalances is thetreatment modalities for DKA. Identification of precipitating factor and frequentpatient monitoring are also important. Non Ketoic Hyperosmolar State [NKHS]:Clincial Features: Polyuria, Orthostatic hypotension, Lethargy, Altered mental status,Obtundation, Seizure and Coma is the clinical features of NKHS.Physical Findings: Dehydration, Hyperosmolality, Hypotension, Tachycardia and Altered mentalstatus are the main physical findings of NKHS.Precipitating Factors: Concurrent illness such as myocardial infarciton, stroke, sepsis, pneumonia,debilitating conditions like dementia are found to be the main precipitating factors forNKHS. ‐ 56- 
  • 70. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Treatment: Correction of dehydration, Insulin administration and Frequent PatientMonitoring are the treatment modalities.(B) Chronic Complications: Chart No. 3 - Mechanism of developing chronic complications62 Hyperglycaemia Endothelial nitric Activation of Formation of Activation of oxide synthase protein kinase C advanced glycation polyol pathway uncoupling end products (AGE) Activation of reactive oxygenease Induction of oxidative stress Induction Reduction of Activation Increased Altered of DNA nitric oxide of protein AGE gene damage bioavailability kinase C formation expression The possible mechanism of complication is yet to be elucidated.Three theories have been proposed for the mechanism of complications. One hypothesis proposes that increased intracellular glucose leads to inceasedsorbitol wich aris a polyol. Some glucose converts into sorbitol by aldose reductase.Increased sorbitol concentrations leading to cellular dysfunction will exhibits thecomplication of Diabetes Mellitus. ‐ 57- 
  • 71. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Second hypothesis suggests that increased intra cellular glucose levels leads tothe formation of Advanced Glycosylation End products (AGEs). AGEs modulateatherosclerosis, accelerate glomerular dysfunction, decrease nitric oxide synthesis,and promote endothelial dysfunction which leads to complication by altered cellfunction. Third hypothesis has been explained in following manner. Increasedhyperglycemia increases the formation of diacylglycerol which activates certainisoforms of protein kinase C, which leads to complications through altered geneexpression or growth factors.Increased level of growth factors such as, Plateletderived growth factor, epidermal growth factor & vascular endothelial growth factorleads to complication of Diabetes mellitus.Glycemic control and Complications: The DCCT (Diabetes Control and complications Trial) results postulated thatimprovement of glycemic control reduced nonproliferative and proliferativeretinopathy, micro albuminuria, clinical nephropathy and neuropathy. The UnitedKingdom Prospective Diabetes study results establish that retinopathy, nephropathyand neuropathy are benefited by lowering blood glucose levels in type 2 diabetes withintensive therapy. The overall complication rate was decreased by 60% with intencetherapy and strict glyceamic control.in patients with type1 diabetes strict glyceamiccontrol achieved a substancially lower HbA1c (7.2%) than individuals in theconventional diabetes management group (HbA1c of 9%).(1) Diabetic Retinopathy: Diabetic Retinopathy is a most frequent cause of blindness among adults aged20-74 yrs. Diabetic retinopathy is classified in to two stages proliferative and nonproliferative. ‐ 58- 
  • 72. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Nonproliferative diabetic retinopathy usually appears late in the first decade orearly in the second decade of the disease and is marked by retinal vascularmicroaneurisms, blot heamorrhages and cottonwool spots. The appearance of neovascularisation in response to retinal hypoxia is thehallmark of proliferative Diabetic retinopathy.they rupture easily and leading to vitrialhemorrhage, fibrosis and ultimately retinal detachment.(2) Diabetic Neuropathy63: Diabetic neuropathy occurs in approximately 50% of individuals withcontinuum of hyperglycemia in type 1 and type 2 diabetes mellitus. It may manifest aspolyneuropathy, mononeuropathy and autonomic neuropathy. PolyneuropathyManifestations:Distal sensory loss, Hyperesthesia, Paresthesia, Pain [usually in lower extremities]Physical findings: Sensory loss, Loss of ankle reflexes, Abnormal position sense, Parethesia[sensation of numbness, tingling, sharpness or burning] Diabetic polyradiculopathy is a syndrome characterized by severe disablingpain in the distribution of one or more nerve roots. Mono neuropathy: It presents with pain and motor weakness in the distribution of a single nerve.Involvement of the third cranial nerve is most common.Physical findings: Ptosis, Opthalmoplegia with normal papillary constriction to light can benoted. Peripheral mononeuropathies or simultaneous involvement of more than onenerve (Mononeuropathy multiplex) may also occur. ‐ 59- 
  • 73. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Autonomic neuropathy: Individuals with long standing type- 1 or type- 2 Diabetes may developautonomic neuropathy involving multiple systems, like the cardiovascular system,genitourinary system, gastro intestmal tract, psudo motor system and metabolicsystems. As a result of sympathetic nervous system dysfunction hyperhidrosis of theupper extremities and anhidrosois of lower extremities occurs which promote dry skinwith cracking. Autonomic neuropathy may reduce counter regulatory hormonerelease, leading to an inability to sense hypoglycemia.3. Diabetic nephropathy: Diabetic nephropathy is an important cause for morbidity and mortality,and isnow among the most common causes of end-stage renal failure(ESRF)in developingcountries. As it is found with other microvascular and macrovascular complications,management is frequently difficult and the benefits of prevention is substantial.About30% of patients with type1 diabetes have developed diabetic neuropathy after 20years and epidemiological data suggested that the over all incidents is declining asstandards of glyceamic control increased.microalbuminuria is an important indicatorof risk developing nephropathy and more reliable for type1 diabetes than type2variety.risk factors for developing diabetic nephropathy includes poor control ofblood glucose,long duration of diabetes,presense of other microvascularcomplications,familyhistory etc.(4) Cardio vascular disease64 Cardiovascular disease is the leading cause of mortality for with diabetes.Type 2 diabetes is an Independent risk factor for macrovascular disease and itscommon coexisting conditions i.e. hypertension & dyslipidemia. Hypertension (blood pressure > 140/90 mmHg) is a common comorbidity ofdiabetes, affecting 20-60% of people with diabetes, depending on age, obesity and ‐ 60- 
  • 74. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)ethnicity. Lowering of blood pressure with regimens based on antihypertensive drugs,including ACE inhibitors, angiotensin receptor blockers (ARBs), B-blockers, diuretics& calcium channel blockers has been shown to be effective in lowering cardiovascular events. Patients with type 2 diabetes have an increased prevalence of lipidabnormalities. Which account for higher rates of CVD. The most common pattern ofdyslipidemia in type 2 diabetic patients is elevated triglyceride levels. Type 2 diabeticpatients typically have a preponderance of smaller, denser LDL particles, whichpossibly increases atherogenicity even if the absolute concentration of LDL is notsignificantly increased. Table No. 10. Abnormal Lipoprotein levels in adults with Diabetes Mellitus. LDL Cholesterol HDL Cholesterol Triglyceude > 130 <40 > 400(5) Gastrointestinal Dysfunctions:65Symptoms: Delayed Gastric Emptying [gastropresis], Altered small & large bowelMotility [Constipation or diarrhoea], Anorexia, Nausea, Vomiting, Early satiety,Abdominal bloating.(6) Genito urinary Dysfunction: • Cystopathy • Erectile dysfunction • Female sexual dysfunction • Dyspareunia • Vaginal Lubrication ‐ 61- 
  • 75. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)(7) Diabetic Foot: 66 Foot ulcers and amputations are a major cause for individuals with diabetes.The risks of ulcers or amputation increased in people who have had diabetes > 10years have poor glucose control have renal, retinal or cardio vascular complications. Clinical features include neuropathy and ischemia which presents withparasthesiae, pain, numbness, claudication, ulcer, gangrene, Osteoomyelitis etc. Table No.11 Complications of Diabetes according to modern and ayurvedic. MODERNVIEW AYURVEDIC VIEW Carbuncles Pidakas Diabetic gangrene Poothimamsatha Gastrointestinal disfunction Pipasa,arochaka,avipakaAtisara Lethargy Dourbalya Genital dysfunction Vrushanayoravadaranam Nephropathy,Retinopathy Saithilyam (Netra, Muthravahasrothas, Neuropathy Nadisamsthanam). ‐ 62- 
  • 76. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) ARISHTA LAKSHANA The following two features are mentioned by Acharya Charaka as arishtalakshana i.e.the signs of incurability or indication of ensured death which are highlyliable for physician’s cognitive discretion.1. According to Acharya Charaka, the person in whose body, the flies are attractedafter bath also is sure to die due to Prameha. 68 The sweetness of body is in large proportion in prameha and after bath also theskin remains sweet. Extensive hyperglycemia may produce diabetic coma and patientmay die.2. Acharya Charaka also says that the person who drinks various kinds of oils andghees or other unctuous preparations with Chandala in his dreams may die of pramehain future.69 This shows the relationship between altered bodily functions in Madhumehaand its impact in the mental status. Unctuous preparations like oils and ghees are therepresentatives of soumya dathus. Here chandala represents the altered status ofsoumya dhathu’s like Vasa, Majja, Ojas, Meda, Kleda etc. ‐ 63- 
  • 77. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) DIAGNOSIS OF DIABETES MELLITUS71 It is the early diagnosis of Diabetes Mellitus which is finding more importancein the Healthcare domain than mere diagnosis, which is also of great importantbecause it helps in two perspectives regarding the management of the disease. 1. Firstly, it helps in defining the threshold for various interventional strategies aiming to control symptoms and ameliorate development of short term and long term complications. 2. Secondly, it helps in epidemiological studies to estimates its prevalence and incidence along with the risk factors which inturn helps to strategise the preventive and therapeutic measures. Amidst the various technological advances in medicative therapy it is the early diagnosis which has still remained as an enigmatic topic of discussion in any stream of medicine. Good news for the Ayurvedic physicians is that they have the emeritus tool for discreting the condition for early diagnosis of this dreadly creeping disease. Diagnostic Criteria Currently accepted diagnostic criteria across the world are those proposed by the expert committee of American Diabetic Association in 1997 and accepted by WHO in 2009. The same criterion used by DCCT for its clinical studies on diabetes mellitus has been used for the present study. ‐ 64-
  • 78. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) TableNo.12. WHO approved Diagnosis Criteria for Diabetes Mellitus WHO approved Diagnostic Criteria of Diabetis Mellitus Venous plasma Capillary blood Fasting ≥126mg/dl >110mg/dl 2 hrs post glucose ≥200mg/dl >200mg/dl Random blood glucose ≥200mg/dl In a patient who is having cardinal symptomatology of diabetes mellitus(Polyphagia, Polyuria, Polydypsia Unexplained Weight Loss, Drowsiness or Coma),Fasting Plasma Glucose Level ≥126mg/dl or 2hrs post 75 gm glucose level ≥200mg/dl is considered as the Diagnostic Criteria for Diabetes Mellitus. Fastingplasma glucose level (FPG) less than 100mg/dl is considered as normal. HoweverFPG level of 101-125mg/dl is considered as IFG (Impaired Fasting Glucose) and isrefered to pre-diabetic condition. TableNo.13 Impaired Fasting Glucose Level Impaired Fasting Glucose Venous plasma Capillary wholebloodFasting 100-125 mg/dl NA2 hrs post glucose ≤140 mg/dl ≤140 mg/dlIf performed ≤200mg/dl ≤200 mg/dlOral Glucose Tolerance Test (OGTT) In asymptomatic individuals, individuals with IFG and those with RandomPlasma Glucose level between 100-200mg/dl an OGTT is strongly recommended fordiagnosis. ‐ 65-
  • 79. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Precautions 1. It should be done in the morning after unrestricted carbohydrate diet and usual physical activity for previous 72 hrs. 2. The subject should be fasting for atleast 10 -16 hours before the test (may drink water). 3. The subject should not be smoking during the test. 4. Any concomitant medication, infection or inactivity must be recorded and be taken into consideration while interpritting the results.Procedure: The test should be performed with 75g of anhydrous glucose in 150 – 300 mlof water over the course of 5 mins. Children should be given 1.75gm/kg of bodyweight, upto a total of 75g glucose. Blood should be collected in a tube containingsodium fluoride (6mg/ml of whole blood) and centrifuged properly to separate out theplasma. Two hours post glucose value of more than 200mg/ dl is considereddiagnostic for diabetes, while values ranging between 140-200 mg/dl are consideredImpaired Glucose Tolerance (IGT). TableNo.14. Impaired Glucose Tolerance Test Impaired Glucose ToleranceTime Venous Plasma Capillary whole bloodFasting(if measured) < 126 Mg/dl or < 7 < 110 Mg/dl or< 6.1 mmol/L mmol/L2 hours post glucose 140- 199Mg/dl or 7.8- 11.0 140- 199Mg/dl or 7.8- 11.0 mmol/L mmol/L ‐ 66-
  • 80. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Glycosylated or Glycated Heamoglobin – HbA1C123 In normal individuals a small proportion of heamoglobin combines with thecirculating blood glucose and this fraction is called glycosylated or glycated Hb. Thiscan be separated in to 3 types HbA1a, HbA1b, and HbA1c. More binding is to HbA1c. The binding of glucose to Hb is a non-enzymatic process that occurscontinuously through out the lifespan of the RBC. Once glycated the elevated levelspersists till the red cell dies. The amount of glycated Hb reflects the efficacy of glycemic control in adiabetic patient during the 8-12 week period before the blood was collected. Normallevel of HbA1C is below 7%. Elevation of HbA1C above this value is evidence of acondition which is in need of glycemic control during the preceding 8-12 weeks. Itreflects the radical changes in diet or modes of therapy approximately 3-4 weeks afterthe initiation of the change. HbA1C is now considered as the most importantdiagnostic criteria which help in detecting an unknown hyperglycemic episode withina span of 2 yrs and the goal of the any treatment in type-2 diabetes being achievingthe HbA1C level <7% along with Fasting and Post Prandial Blood Sugar Levelbetween 90-130 mg/dl and below 180 mg/dl respectively. Commonly used techniques for its measurement are chromatographic andthiobarbitone calorimetric method. It is wise enough to keep in mind that the interlaboratory variations are high due to lack of standardization. There are few factorswhich influence falsely elevated levels of HbA1C and they are, 1. Fructose rich diet. 2. Hyperlipedemia. 3. Uremia. ‐ 67-
  • 81. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) 4. Elevated temperature and elevated pH of the blood.There are few factors which influence false low values like, 1. Pregnancy. 2. Anemia. 3. Post blood transfusion period. 4. Low temperature and low pH of the blood.Advantages: 1. It is useful for assessing long term blood sugar control. 2. The levels of the blood glucose can be easily manipulated by the patients by taking extra dose of the OHA or insulin or even missing meals on the day of test so that patient can get good results but HbA1C is unaffected by time, type of blood sample either venous or capillary, even fed or fasting state.Disadvantages: 1. It cannot help in diagnosing hypoglycemic episodes or even diabetic ketoacidosis. 2. It is sometimes possible to obtain normal values in patients suffering from frequent and dangerous episodes of hypoglycemia, if these are balanced by other episodes of excessive hyperglycemia. 3. It is highly dependent on the life span of the RBC. 4. If it is measured by electrophoretic method and patient who drink 30 or more units of ethanol per week then the values may be higher due to the acetaldehyde derived from the ethanol binds non enzymatically to side chain of Hb which moves in same direction. This is ovecomed through electroendosmosis method. ‐ 68-
  • 82. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) 5. It is not useful for day-to-day management and in adjusting the dose of insulin or oral anti diabetic drugs.RELATION TO THE DIABETIC COMPLICATIONS: The process of glycation is highly indicative of susuceptibility for short termand long term Microvascular and Macrovascular complications as well as variousneural dysfunctions. Thus it is also indicative of the extent and rate of progression ofretinopathy and neuropathy although the genetic determinants of tissue susceptibilityand independent triggering factors like HTN can also influence the clinical course in avaried degree of manifestation.PROPHYLACTIC MEASURES FOR GLYCATION:Based on recent studies it is now known to the conventional stream about the meritand demerits of thiamine pyrophosphate and aminoguanide with its analogues as theprophylactic measures in inhibiting the rate of formation of AGEs but, since it has itsroot in the rate and extent of immunoresponsive tissue response and its respective endproducts with its timely elimination from the system which is still an enigmatic topicfor its clinical execution from the conventional stream due to its limited extent of anti-oxidant therapy.DETECTION OF URINE SUGAR72 The time honoured test for qualitative detection is by boiling urine with coppercontaining fehling’s reagent or benedict’s reagentwhich is reduced by glucose and theblue colour is changed to yellow through red depending upon the amount ofglucose.Eight drops of urine(0.5ml) are added to5mL of benedict’s reagent and boiledfor 2 minutes,cooled and colour is noticed.Sugars reduce the copper and producecolours ranging from green to brick red,depending upon their concentration.this ‐ 69-
  • 83. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)colour is compared to the colour of the reagent before heating.this test is nonspecificsince several sugars like fructose, lactose, galactose, aspirin, VitC and many drugsmay give a positive result. Specific test for glucose is the glucoseoxidate test,test papers beingavailablecommercially,based on specific enzyme mediated reactions which can also bequantitated.Test strips are unaffected by the other sugars or drugs.CLINICAL SIGNIFICANCE: The high blood glucose causes more glucose to filter into the renal tubulesthan can be reabsorbed, and the excess glucose spills into the urine.This normallyoccurs when the blood glucose concentration rises above 180 mg/100 ml, a level thatis called the blood “threshold” for the appearance of glucose in the urine.When theblood glucose level rises to 300 to 500 mg/100 ml—common values in people withsevere untreated diabetes—100 or more grams of glucose can be lost into the urineeach day. ‐ 70-
  • 84. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) SADHYASADHYATA Prognosis forms the Culminative part of Chikitsa so far as a wise physicianand his discrete plans of treatment are concerned. Success of the treatment depends onan unbiased prognosis; but in this condition in the present era, it is liable for discretionbased on Vikara Vighata Bhava Abhava Prativishesha. Generally the concept ofprognosis in the case of Madhumeha is given by all acharyas as Kaphaja Madhumeha-Sadhya, Pittaja Madhumeha-Yapya and Vataja Madhumeha-Asadhya, when occurreddue to Dhatukshaya and Krichrasadhya when the whole pathology underlying is wellestablished due to avarana.Prognosis of Kaphaja Madhumeha Charakacharya illustrated the prognosis of this disease by considering thepresence or absence of poorvarupas. Kaphaja meha with poorvarupas are consideredKrichrasadhya while the one associated with pittaja meha is described asPratyakhyeya. Acharya Chakrapani opines that, appearance of poorvarupa in the latteris a cardinal sign of incurability; which, as a general rule can be applied to any diseasebut with discretion. Here in the context of Madhumeha, the presence of all or fewpoorvarupas like Visrasharirgandham can be considered as asadhyatva. The second concept of prognosis is connected with medodushti .If themedodushti is to a lesser extent, then the disease can be easily cured.So it is importantto consider the gradation of poorvarupas as well as the extent of medodushti forhaving a concept of prognosis in meha. Keeping the above concepts in mind, thesadhyasadhyata can be derived as Kaphaja meha is Sadhya, Kaphaja meha associatedwith few poorvarupas is Krichrasadhya, Kaphaja meha having all the poorvarupas isAsadhya, Kaphaja meha with severe medodushti is Asadhya, Kaphaja meha with bothprofound medodushti & poorvarupas is Asadhya, Kaphaja meha & associated ‐ 71- 
  • 85. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)congenital factors is Asadhya and Kaphaja meha with few poorvarupas but withsevere medodushti is Asadhya.Prognosis of Pithaja and Vathaja Madhumeha Pitaja Madhumeha is considered as yapya, while Vataja madhumeha arehaving the status of Asadhyatva. This is the result of the nature of disease andassociated dhatus.Kaphaja meha can be treated with katu, tikta& kashaya rasas, thenboth the kapha dosha and the associated Samadhatus can also be treated with the sametreatment at the same time. In case of Pittaja Madhumeha and Vataja Madhumeha, thedisease and associated vitiated dhatus are having opposite qualities. So yapyatva &asadhyatva arises respectively. Pitaja Madhumeha is explained to be with this status.The disease requirescontinuous treatment. Once the treatment is stopped the disease is again provoked.Also Vishamakriyatvat i.e. the doshas are conquered by Langhana Therapy but theassociated vitiated dhatus suffer simultaneously. This also leads to yapyatva.Prognosis of Madhumeha Madhumeha in terms of specific type and asadhyata is one among the VatajaPrameha explained. Here vata provocation might be due to sarvadhatukshaya as itoccurs after kaphaja & pittaja Madhumehas. Another important cause is Avarana.When vata provocation is due to dhatukshaya the type is included in asadhyaMadhumeha, while the other produced by avaranjanaya vata is considered asKrichrasadhya. Charakacharya mentioned that Madhumeha produced due tobeejadosha is incurable. Considering all possibilities the prognosis of the disease Madhumeha can besummarized as follows. ‐ 72- 
  • 86. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)MODERN PERSPECTIVE ON PROGNOSIS: Diabetes is not a curable disease; the treatment Strategy is to enable patients tolead lives Similar to those of healthy persons, while preventing complicationsthrough appropriate timely Treatment and Personal Management. To achieve thisobjective, it is important to reduce Psychological, Physical, and Lifestyle Burdens andrestrictions due to diabetes as much as possible. So, evaluation of health-relatedquality of life (HRQL) is of more important for evaluating the burden on patients andin selecting appropriate therapeutic method. Health Related Quality of Lifemeasurement provides a Comprehensive evaluation of the patient’s health statuswhich would provide additional Information to laboratory data and also with thesubjective symptoms which in turn Indicates the Importance of Dinacharya andRutucharya for both healthy and unhealthy Individuals. ‐ 73- 
  • 87. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) CHIKITSA The principles of the therapeutic measure form the core part of the strategiesfor the proper management of the disease especially if Madhumeha is taken intoconsideration because of peculiar vyadhi swabhava and Atura. The samprapti shouldbe considered deeply before stepping into the management.CHIKITSA SUTRA: The eminent ancient ayurvedists, Charaka, Sushruta and Vagbhata areconsidering the body constitution and strength of the body of the patient when dealingwith the management aspect.Charakacharya considers two types of patients, one isthat with stout body structure and with strength and the other without strength andkrisha. Sushrutacharya also says that sahaja meha rogi will be krisha andapathyanimittaja rogi will be sthula.73 In the context of medoroga, the managements described are parallel to that ofmeha since the dosha and dushyas are same to major extent. After considering all thefactors the two types of management emphasised are:(1) Samshodhana Chikitsa: [Elimination Therapy](2) Samshaman Chikitsa: [Normalizing Therapy] Like every disease, those factors which are responsible for the production ofthe diseases are if eliminated and if further, causative factors are prevented meha canalso be treated. Madhumeha can be treated in this way although it is described asincurable. In Pratyakhyeya vyadhis, symptomatic relief can be given by propermanagement. -75- 
  • 88. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)KAPHAJA PRAMEHA: (i) Samshodana Chikitsa: It is better to treat the patient with vaman therapy. Charakacharya describesthat shodhana, vamana and langhana done at the proper time looking at the conditionof the patient is able to cure kaphaja meha. 74 For Bastichikitsa Vagbhata describes the utilization of Surasadi gana kwatha.Acharyas after explaining the shodhana treatment give samshaman Chikitsa in everytype. (ii) Samshamana Chikitsa: Charakacharya gives 10 combinations of drugs to all the mehas with kapha 75predominance. According to Sushruta, after proper samshodhana the patient should useswarasa of amalaki with Haridra powder with madhu.76 Acharya Sushruta in this context explains single drug decoctions with separateindications in 5 types of kaphaja meha and combinations in other 5 types.77 Vagbhatacharya describe three yogas in this aspect. They are as followsLodhradi- Lodhra, Abhaya, Musta, KatphalaPathadi - Patha, Vidanga, Arjuna, DhanyakaGayatrayadi - Khadirsara, Darvi, Vidanga, Vacha 78Importance of Apatarpana: Charakacharya explains the cause of prameha as due to increasing attitude ofkleda, meda and kapha. So he emphasise the role of Apatarpana in kaphaja andPittajaprameha79. Different types of vyayama, kshut, udvartana, dhara and snana with churnasmade of Chandana, Aguru, and Ela etc. are advised to use in kaphaja meha.80 -76- 
  • 89. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)PITAJA PRAMEHA: (i) Samshodhan Chikitsa: Virechan is best in pittaja pramehas. The drugs which are sufficient toeliminate morbid pitta can be used with sheeta and other tikta, kashaya rasa in this.Nyagrodhadi gana kwatha is advised for Asthapanbasti by AcharyaVagbhata.Acharya Sushruta has described that due to spreading of medo dhatu allover the body, Madhumehi subjects are durvirechya.81 (ii) Samshaman Chikitsa:Acharya Charaka explains 10 pada yogas in this aspect to treat pittaja pramehas.Sushrutacharya has described 6 specific kwatha yogas for the specific type of pittajaprameha. 82The three kwatha yogas explained by Acharya Vagbhatta are,Ushiradi: Ushira, Lodhra, Arjuna, Chandana.Patoladi: Patola, Nimba, Amalaki, AmritaLodhradi: Lodhra, Ambu, Kaleyaka, Dhataki83VATAJA PRAMEHA: Although vatika mehas are incurable still Acharya Charaka explains to inducecertain treatment in kaphapittanubandhi Vatika meha84. Achrya Sushruta has described that all types of prameha if not treated properlyin time, gets converted into Madhumeha.85 So the treatment described for vatika mehacan be considered as treatment of Madhumeha.MADHUMEHA: (i) Samshodhana Chikitsa: 86 Considering Sthula and krisha pramehi, Samshodhana Chikitsa should beadministered only to the Sthula and Balvan Pramehi86. Sarshapa, Nimba, Danti, -77- 
  • 90. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Vibitaki and Karanja siddha Taila or Trikantakadya Sneha (Ghrita or Taila) accordingto dosha predominance should be used for Abhyantara Snehana. Here whileexplaining the Samshodhana, Charaka describes to use the Malashodhan yogas fromKalpasthana. Both Pitta and kapha are eliminated through shodhana. It may bevamana or virechana, because of; Pittantam Vamanam, Kaphantam Virechanam. InVirechana pitta is eliminated first, then Samyak lakshana of virechana iskaphadarshan, so both pitta and kapha doshas which are vitiated are eliminated. Thenthe described Anuvasana and Asthapana Basti chikitsas are able enough to control theprovocation of vata. Like this all the doshas are normalized to keep the doshasamyata. Anuvasana with medicated oils and ghritas are prescribed in Madhumeha.After proper Shodhan Chikitsa, Charakacharya details to give santarpan chikitsa to thepatients, to prevent the complications like Gulma, Bastishula etc. (ii) Samshamana Chikitsa: Samshamana Chikitsa includes mainly deepana (appetizers) , Pachana,(enhancing digestion), Kshut (Hunger maintenance), Trit (Maintenance of thirst),Vyayama (Exercise), Atapa (Having exposed to sunlight ) and Maruta ( Exposingoneself to wind).According to the conditions of vitiated doshas & dushyas , vaidyahas to suggest proper Shaman Chikitsa to the patient. Acharyas introduces different tarpana upakramas in vatika mehas. It is due tothe less strength of the patient. Acharya Charaka and Vagbhatta says that the kashayayogas should be enriched with sneha and given to vatika mehas.Typical Madhumeha Chikitsa: 87 Acharya Sushruta explains that Shilajit should be taken after triturating withSalsaradi gana kwatha. After its digestion patient should take JangalamamsarasayuktaAnna. He prescribes to take 1 Tula of shilajatu. -78- 
  • 91. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Swarasa: Amalaki, Haridra, Nimbapatra, Bilwapatra, GuduchiKwatha: Vidangadi, Phalatrikadi, Mustadi, Manjishthadi, PathadiChurna: Triphaladi, Mustadi, Gokshuradi, ArkadiGutika: Chandraprabha, Indravati, Pramehantak VatiGugglu: Gokshuradi GuggulModaka: Kastur ModakaAvleha: Kushavleha, BangavlehaPaka: Pugapaka, Ashwagandhadi paka, Draksha Paka.Asava Arishta: Lodhrasava, Dantyasava, Madhukasava, Devdarvyadiarishta,Lodhrarishta.Ghrita: Dhanvantar ghrita, Trikantakadi ghrita, Sinhamrita ghrita, Dadimadi ghrita,Shalmali ghrita.Rasaushadhi:Vasant kusumakar Rasa, Mehamudgar Rasa, Brihat Bangeshwar Rasa,Prameha gajkesri Rasa, Tribanga Bhasma, Vasant tilaka Rasa.TREATMENT OF DIABETES MELLITUS88Goals of treatment of diabetes: Diabetes mellitus requires ongoing medical care as well as patient and familyeducation both to prevent acute illness and to reduce the risk of long termcomplications. The management of diabetes patient is not aimed solely at glycemiccontrol to restore known metabolic derangements towards normal in order to preventand delay progression of diabetic complications. The aims of treatment have beenvaried according to an arbitrary division of patients into three categories ranging fromthose in whom symptomatic relief done seems the most appropriate or any attainablegoal to those in whom an attempt at maximal prophylaxis against future tissuedamage seems desirable and possible. -79- 
  • 92. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) 89Oral Drugs for Treating Hyperglycemia: Oral drugs are used to lower Bloodglucose level by achieving following goals.1. Drugs that primarily stimulate insulin secretion2. Drugs that alter insulin action.3. Drugs that principally affect absorption of glucose.Mainly used drugs are Sulphonylureas and Biguanides.Sulphonylureas: These drugs stimulate production of Insulin initially but later onthey act by their extra pancreatic actions. These include reduced hepatic release ofglucose and improved sensitivity to Insulin, possibly due to an increase in number ofperipheral Insulin receptors. Sulphonylureas are mainly indicated for Maturity onsetDiabetics of average weight not controlled by diet alone. The contraindicationincludes juvenile Diabetes, Ketosis, patients taking Insulin and presence of renal,hepatic, cardiovascular disease or alcoholic abuse. Hypoglycemia, dyspepsia, skinrashes, facial flushing after ingestion of alcohol are the most frequently encounteredside effects with sulphonylureas. E.g. Tulbutamide, Chlorpropamide etc.Biguanides: There major effect is to increase the peripheral uptake of glucose and inlarge doses to delay or decrease intestinal absorption. These are the drug of choice forthe treatment of maturity onset obese diabetic patients who have failed to lose weighton diet. Biguanides are also used in combination with sulphonylureas to enhance theinadequate or failing effects of the latter. But these affect the gastrointestinal tractadversely and the incidences of death from lactic acidosis are substantially high. Theadverse effects include metallic taste in mouth, anorexia, nausea, dyspepsia, diarrhea,malaise, weakness, drowsiness, lactic acidosis and lastly the vitamin B12malabsorption after prolonged treatment. E.g. Phenformin, Metformin, etc -80- 
  • 93. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)ORAL HYPOGLYCEMIC AGENTS: TableNo.16 Oral Hypoglycemic Agents Drug ActionAgent Mechanism of Example Anticipated Agent Specific Action Reduction Advantages in HbA1C%Insulin Insulin Glipizide Lower fastingSecretagogues 1-2 blood glucoseSulfonylureas Repaglinide Short onset ofMeglitinide action,lower PPBGBiguanides Hepatic glucose Weight loss, production, , 1-2 Improve lipid glucose utilization Metformin profile, No hypoglycemcaAlpha- Delay Glucose Acarbose 0.5-1 No risk ofGlucosidase absorption in the Gut miglitol hypoglycemiainhibitorsThizolidinedio Insulin resistance Rosiglitazone 1-2 Insulin &nes Proglitazone Sulfonylurea requirements, triglycerides.Insulin:Insulin is indicated for type - I diabetic as well as for type - II diabetic patients withinsulinopenia whose hyperglycemia does not respond to diet therapy either alone orcombined with oral hypoglycemic drugs. Insulin injections are very much necessaryin severs conditions of hyperglycemia. There are various preparation are presentdepending upon their purity, solubility and species (like Human/Bovine).Type of Insulin: Apart from the species difference, seven types of Insulin arecommercially available. They may be divided into Insulin of fast, intermediate and -81- 
  • 94. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)long action (Harrison, 1981). They may also be called Soluble Insulin, ProtamineInsulin and Insulin zinc suspension. Highly purified, semi-synthetic human Insulinoffers a safe and effective means to explore the possible advantages of homologoushuman Insulin in the management of Diabetes mellitus.Choice of Insulin: Crystalline Insulin is best for emergencies such as for thetreatment of Diabetic Ketoacidosis. It is also employed for daily use in combinationwith intermediate Insulin to bring on earlier action.Treatment of Chronic Complications:Multidisciplinary approach is recommended for persons with complications ofdiabetes.To reduce the risk and slow down the progression of nephropathy, glucose control andblood pressure control should be optimized along with Specific treatment of thecomplications such as laser photocoagulation in diabetic retinopathy etc..Steps in the management of Diabetic Patients:Diagnostic Examination: All necessary investigations should be done for thediagnosis including all systemic examinations along with proper history.Patient Education (Self Management Training): Since diabetes is a life longdisorder, education of the patient and family members is probably the most importantobligation of the physician.ADVICE:Check Regular Blood Glucose Level: Self monitoring of blood glucose may beadvice to the patients as it has provided greater flexibility in management whileachieving improved glycemic control.Diet Control Therapy: Treatment must be individualized on the basis of type ofDiabetes and specific needs of each patient. -82- 
  • 95. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Both modern medicine and ayurveda emphasize the importance of regulation of highcalorie diet and observation of probable mode of exercises.PATHYA-APATHYA90 Those Aaharas and viharas which are suitable to the disease condition arecalled Pathya and those which promote severity of disease are called Apathya. Pathyais having a key role in the management of Madhumeha. Even in modern science alsoDiet & Exercise are included in diabetes management. So before stepping tomanagement we have to consider for the Pathya-Apathya. Pathya and Apathya Aharasand Viharas according to different Ayurvedic classics are as follows:Pathya: 91(a) Aahara:Shook Dhanya: Jeerna Shali, Shashtika, Kodrava, Yava, Godhuma, Uddalaka,ShyamakaShimbi Dhanya: Chanaka, Adhaki, Kulattha, MudgaShaka Varga: The leafy vegetables with a predominance of tikta-kashaya rasa,Patola, Karvellaka, ShigruPhala Varga: Jambu, Dadima, Shringataka, Amalaki, Kapittha, Tinduka, Kharjura,Kalinga, Navina Mocha.Mamsa Varga: Vishkira mamsa, Pratuda, Jangala mamsaTaila Varga: Danti, Ingudi, Sarshapa, AtasiUdaka Varga: Sarodaka, Kushodaka, MadhudakaKritanna Varga: Apupa, Saktu, Yavodana, Vatya, YushaOthers: Madhu, Hingu, Saindhava, Maricha, Lasuna -83- 
  • 96. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)(b) Vihara: To have walks, travelling on elephants, horses and different plays, differentform of marshal arts, roaming in different places without chappal and umbrella.Apathya: 92(a) Ahara: Jala, Milk, Ghee, Oils, Curd, Sugar, Different types of rice preparations,anupa, gramya and audaka mamsa, Ikshurasa, Pishtanna, Navannan, sauveraka,suramadya, suktha, Amlarasaahara, sugarcandy juice,.(b) Vihara: Eksthana asana, Divaswapa, Dhoompana, Sweda, Raktamoksha,Mutravega dharana.TREATMENT REGIMENS: MODERN VIEWS.Diet: A well-balanced nutritious diet remains a fundamental element of therapy. Inobese patient with mild hyperglycemia the major goal of diet therapy is weightreduction by caloric restriction. Dietary treatment of Diabetes still constitutes thebasis for management, so that it is believed even today that 50% of diabetics could beput to control only by judicious dietary regimen. The chief aims of diabetic diet are: 93a) Achieve good glyceamic controlb) Reduce hyperglyceamia and avoid hypoglyceamiaPrevent hypoglycemiac) Obtain ideal body weight.d) Reduce the risk of micro and macrovascular complications.e) Ensure adequate dietary intake.Type of Diet: Basically there are two types of diet:Unmeasured Diets: If Insulin or oral hypoglycemic agents are not required andmarked obesity is not present it may not be necessary for the patient to follow such anaccurate diet. -84- 
  • 97. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Forbidden Foods: Sugar, Jam, Honey, Tinned fruits, Sweets, Chocolates, GlucoseDrinks, Food made with Sugar, Cakes, Sweet Biscuits, Puddings, Rice and alcoholicdrinks.Foods allowed in moderation: Chapatis made from wheat or millets, peas and backedbeans, breakfast cereals and all fresh and dried fruits, custard.Free Foods: Eggs (not fried), vegetables such as cabbage, cauliflower, brinjal, lady’sfinger, French beans, cucumber, lettuce, tomato, spring onion, radish, asparagus,lastly the saccharine for sweetening.Measured Diet: These are required for patients who are being treated with Insulin ororal hypoglycemic agents and also for those who are overweight and are on a antiobese regimen.NUTRITON: 94Medical Nutrition Therapy (MNT) is an integral component of Diabetes Management.Nutritional Recommendations for Diabetics:Carbohydrate: Whole grains, fruits, vegetables and low fat milk should be includedin the healthy diet. The total amount of carbohydrate in diet is more important thansource or type. As sucrose does not increase glycemia to a greater extent thanisocaloric amounts of starch, sucrose and sucrose containing foods do not need to berestricted.Protein: Protein intakes > 20% of total daily energy should be avoided.Fat: Less than 10% of energy intake should be derived from saturated fats.Cholesterol: <300 mg/day. Individuals with LDL>100 mg/dl should take cholesterol<200 mg/day. -85- 
  • 98. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Vitamins and Minerals: As there is no evidence of benefit from it, vitamins andminerals are not advisable if person do not have underlying deficiencies.Antioxidant: Routine supplementation of antioxidants is not advised because ofuncertainties related to long term efficacy and safety.Calorific Requirements: The approximate ratio in normal person’s diet is protein12%, fat 42% and carbohydrate 46%, but in diabetics it is usually needed to bemodified as protein 15%, fat 35% and Carbohydrate 50%. In Insulin requiring Diabetics the distribution of calories is very important toavoid the hypoglycemia. A typical patient of IDDM usually require 20% of totalcalories for breakfast, 35% for lunch, 30% for the dinner and 15% for the late eveningfeedings. (Harrison 1997)EXERCISEExercise and Type 1 diabetes: The ability to adjust the therapeutic regimen (Insulinand MNT) to allow safe participation has been recognized as an importantmanagement strategy in these individuals. The individual with type 1 DM should follow these guidelines: a. Metabolic control before physical activity. b. Avoid physical activity if Fasting glucose > 250 mg/dl and ketosis is present. c. Ingest added carbohydrate if glucose level < 100 mg/dl d. Blood glucose monitoring before and after physical activity. e. Food intake – Carbohydrate based foods should be readily available to avoid hypoglycemia.Exercise and Type 2 diabetes: The possible benefits of physical activity for thepatient with type 2 diabetes are substantial, and recent studies strengthen the -86- 
  • 99. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)importance of long term discrete physical activity programs for the treatment andprevention of Diabetes mellitus. It reduces the risk of cardiovascular disease,Hyperlipidemia, Hypertension and Obesity. Recent studies reveal that exerciseincreases Adiponectin levels and thus increase Insulin Sensitivity in humans.DIABETIC QUALITY OF LIFE: The World Health Organization (WHO) has established two main objectivesin caring for diabetic patients: first, maintain the health and quality of life ofindividuals with diabetes through effective patient care and education and second,treat and prevent complications of the disease which should decrease morbidity andmortality as well as increase the therapeutic compliance of the patients. The above elucidated Ayurvedic and Conventional modalities of treatment areall aimed at bringing about good metabolic control at different levels of normalphysiological process of digestion, but achieving good metabolic control has beenfound difficult in children, and particularly in adolescents. Having diabetes requires acomplex, intrusive and highly demanding daily programme for families with one ormore diabetic members in the family, which may have a negative effect on Quality ofLife (QOL). Good Quality of Life is associated with better metabolic control and it isthe subjects general and health related Quality Of Life which is gaining maximumfocus and has become an important outcome in any clinical studies and healthcareinterventions.The World Health Organization (WHO) defines QOL as an “individual’s perceptionof their position in life in the context of the culture and value systems in which theylive and in relation to their goals, expectatctions, standards and concerns. It is a broadranging concept, affected in a complex way by the person’s physical health, -87- 
  • 100. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)psychological State, personal belief and social relationships to salient features of theirenvironment”.Other experts suggest that QOL is a multidimensional, subjective anddynamic concept.In medical sciences, QOL is used in 2 ways: general QOL or the general feeling ofwell-being and health-related QOL, involving health-related problems for differentdiseases. A number of questionnaires are available covering both aspects. The oneaccepted and validated from the Diabetes control and complications trial – DCCT andalso world health organization approved field test instruments with questionaires canbe used for various clinical study.The Future of Diabetes: Scientists are now testing whether giving insulin injections or a pill might keeppeople from getting diabetes, at least for a little while. Scientists are convinced thatsome day in the future a treatment can be used to vaccinate all children againstDiabetes. Since 1971, scientists have been trying to create an artificial pancreas to tryto cure diabetes in people who clearly have it. With an artificial pancreas, a personwith diabetes could have controlled blood sugars without having to inject insulin. Theartificial pancreas is still years away, but scientists are confident that it is possible. -88- 
  • 101. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) DRUG REVIEW Proper understanding of the characteristic features of the drug is veryimportant prior to the treatment procedure. This aspect has been well highlighted byAcharya Charaka, That drug, its pharmacodynamics and pharmacokinetics mentioned in theAuthentic Vedic Dictionaries – Nighantu, if not well assimilated by the administratingphysician then, it is not too far in bringing about deadly, harmful, severe adverseevents in the subject, just like a dreadful poison, dreadly weapons and a dangerouslightning flash in bringing about the untowards effect. So, it is mandatory to be wellaware of pharmacological properties and actions of the individual drugs within theinvestigational product. Madhumeha, as already mentioned occur either due to Avaraka doshas likeKapha and Pita within the Srotas’s thus interfering with the normal pathway of vayu.So, Samprapti Vighatana forms the basic core for treating this diseased condition. TheShamana Yoga selected for the present study comprises of seven drugs which are veryeasily available and hypothesized to have the ability of breaking the above viciouscycle of pathology along with Mehagna action synergistically.VATSAKADI QWATHA110: The reference for Vatsakadi Qwatha is available in Qwatha KalpanaAdhyaya of the Sharangadhara Samhita containing Vatsaka, Haritaki, Vibhithaki,Amalaki, Daruharidra, Musta and Bijaka as the ingredients taken in equal quantities. The descriptions of these ingredients with regards to their nomenclature,Chemical Composition, Classical Pharmacological Properties and Actions along withtheir Humoral Effects and updated studies related to pre-clinical and clinicalevaluation are enlisted hereafter. ‐ 90‐ 
  • 102. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) TableNo.16 Pharmacodynamic properties of the drugs used in the formulation125 Drug Rasa Guna Virya Vipaka Doshagnata C.C1241 Vatsaka Tikta Laghu, Sheeta Katu Kapha Pitha Anthraquinone Kashaya Ruksha Upashoshana glycosides, Alkaloids, Flavanoids.2 Haritaki Lavana Laghu, Ushna Madhura Tridoshagna, Tannins, Varjitha Ruksha Chakshushya, A. glycosides, Pancha Medohara, Polyphenolic Rasa Jvara↓ compounds3 Vibhitaki Kashaya Laghu, Ushna Madhura Kaphapithagna Tannic acid, Ruksha Jvara↓ Gallic acid, Glycosides.4 Amalaki Lavana Laghu, Sheeta Madhura Tridoshagna Ascorbic acid Varjitha Ruksha Jvara↓ Pancha Rasa5 Darvi Tikta Laghu, Ushna Katu? Kaphapithagna Alkaloids Ruksha Dosha Pachaka6 Musta Kashaya, Laghu, Sheeta Katu Kaphapithagna Volatile oils Katu, Ruksha Medohara Tikta Trushna↓7 Bijaka Kashaya, Laghu, Ushna Katu Kaphapithagna Tannins. Katu, Ruksha Medohara Bio Flavanoids Tikta Udarda↓ ‐ 91‐ 
  • 103. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)VATSAKA125Gana : Arsoghna, Kandughna etcFamily : Apocynaceae.Latin Name : Holarrhena antidysenterica (Roth) A.DCChemical Constituents : Conessine and related alkaloids.Therapeutic Action : Deepana, Samagrahi, Upashoshaka.Therapeutic Uses : Pravahika, Atisara, Arsha, Trushna.Therapeutic Form and Dose: Stem Bark Decoction 20-30ml.RECENT STUDIES124: 1. Anti-Bacterial activity of Holarrhena antidysenterica against enteric pathogens118. 2. Anti-Bacterial steroid alkaloids from the stem bark of Holarrhena antidysenterica119. 3. Anti-Diarrhoeal and Anti-Microbial activity of Holarrhena antidysenterica119. 4. The in vitro Antioxidant activity and total phenolic content of four Indian medicinal plants119. 5. Hepatoprotective activity of Holarrhena antidysenterica. 6. Cardioprotective activity of Holarrhena antidysenterica. 7. Anti Inflammatory activity of Holarrhena antidysenterica. ‐ 92‐ 
  • 104. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)HARITAKI125Gana : Amalakyadi, Haritakyadi, Parushakadi, Trivruthadi, Prajasthapana, Jvaraghna, Kustaghna.Family : CombretaceaeLatin Name : Terminalia Chebula. RetzChemical Constituents : Tannins – 30% Chebulinic acid, 45% Tannic acid, Gallic Acid, resins etc, Anthraquinones and Polyphenolic Compounds.Therapeutic Action : Sarvadoshaprashamana, Rasayana, Deepana, Anulomana.Therapeutic Uses : Vibandha, Aruci, Udavarta, Gulma, Udararoga, Arsha, Pandu, Shotha, Jeernajvara, Vishamajvara, Prameha, Shiroroga, Kasa, Tamaka Shwasa, Hrdroga.Therapeutic Form and Dose: 3-6 g of the drug in Powder form.RECENT STUDIES124: 1. Anti Mutagenic activity of Terminalia chebula. 2. Cardioprotective activity of Terminalia chebula. 3. Anti hemorrhagic activity of Terminalia chebula. 4. Anti Hyperlipidemic activity of Terminalia chebula. 5. Anti viral activity of Terminalia chebula119. 6. Anti parasitic activity of Terminalia chebula119. 7. Retinoprotective activity of Terminalia chebula. 8. Anti Inflammatory activity of Terminalia chebula. ‐ 93‐ 
  • 105. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)AMALAKI125Gana : Triphala, Parusakadigana (Susruta), Vayahsthapana, Virechanopaga (Charaka)Family : EuphorbiaceaeLatin Name : Emblica officinalis Gaertn. Syn. Phyllanthus emblica LinnChemical Constituents : Vitamin C, Tannin, Gallic acid, Tannic acid.Therapeutic Action : Tridoshahara, Vrshya, Rasayana, Cakshushya.Therapeutic Uses : Raktapita, Amlapita, Prameha, DahaTherapeutic Form and Dose: 3-6 g of the drug in powder form.RECENT STUDIES124: 1. Nephroprotective activity of Emblica officinalis. 2. Neurotonic effect activity of Emblica officinalis. 3. Anti carcinogenic activity of Emblica officinalis. 4. Anti Hyperlipidemic activity of Emblica officinalis. 5. Anti Ulcerogenic activity of Emblica officinalis119. 6. Anti Oxidant activity of Emblica officinalis119. 7. Anti Inflammatory activity of Emblica officinalis. 8. Anti Hyperglycemic activity of Emblica officinalis. ‐ 94‐ 
  • 106. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)VIBHITAKI125Gana : Jvarahara, Virechanopaga.Family : CombretaceaeLatin Name : Terminalia belerica Roxb.Chemical constituents : Gallic acid, Tannic acid and Glycosides, Fructose, Galactose, Glucose, Mannitol.Therapeutic Action : Kaphapitagna, Bhedaka, Krimigna, Cakshushya, Keshya.Therapeutic Uses : Svarabheda, Netraroga, Kasa, Chardi, Krimiroga, VibandhaTherapeutic Form and Dose: 3-6 g of the drug in Powder form.RECENT STUDIES124: 1. Retinoprotective activity of Terminalia belerica119. 2. Anti Hyperlipidemic activity of Terminalia belerica. 3. Anti platelet aggregation activity of Terminalia belerica. 4. Anti hyperglycemic activity of Terminalia belerica. 5. Anti inflammatory activity of Terminalia belerica. ‐ 95‐ 
  • 107. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)DARUHARIDRA125Gana : Arsoghna, Kandugna, Lekhaneeya (Ch); Haridradi, Musthadi, Lakshadi (Su)Family : BerberidaceaeLatin Name : Coscinium fenestratumChemical constituent : Berberine.Natural Habitat : SriLanka, Southern belt of Karnataka.Therapeutic Action : Stanya Shodhana, Stanya Doshahara, Dosha PacanaTherapeutic Uses : Amatisara, Medoroga, Urustambha, Karnaroga, Mukharoga, Netraroga, Vrana, Meha.Therapeutic Form and Dose : 5-10 ml of the drug in Qwatha form.RECENT STUDIES124: 1. Retinoprotective activity of Coscinium fenestratum119. 2. Anti cancer activity of Coscinium fenestratum119. 3. Anti septic activity of Coscinium fenestratum119. 4. Hepatoprotective activity of Coscinium fenestratum119. 5. Nephroprotective activity of Coscinium fenestratum119. 6. Cardiotonic activity of Coscinium fenestratum119. 7. Anti ulcer activity of Coscinium fenestratum119. 8. Anti inflammatory activity of Coscinium fenestratum119. ‐ 96‐ 
  • 108. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)MUSTA125Gana : Kandugna, Stanya Shodhaka - CharakaFamily : CyperaceaeLatin Name : Cyperus rotundus.Chemical constituents : Volatile oilsTherapeutic Action : Pitakaphahara, Sthoulyahara, Shotahara, Deepana, Pacana, Grahi, Trushnanigrahana, Krimigna, Tvak doshahara, Jvaragna, VishaghnaTherapeutic Uses : Agnimandya, Ajirna, Trushna¸ Jvara, Samgrahi¸ Mutrakruchra, Stanyavikara, Sutikaroga, Atisara, Amavata, Krimiroga.Therapeutic Form and Dose: 3-6 g (Powder), 20-30 ml (Kwatha)RECENT STUDIES124: 1. Anti diarrheal activity of Cyperus rotundus119. 2. Anti Hyperlipidemic activity of Cyperus rotundus119. 3. Hepatoprotective activity of Cyperus rotundus119. 4. Anti Bacterial activity of Cyperus rotundus119. 5. Anti Inflammatory activity of Cyperus rotundus119. 6. Anti Oxidant activity of Cyperus rotundus. ‐ 97‐ 
  • 109. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)BIJAKA125Gana : Udarda Prashamana – Charaka.Family : FabaceaeLatin Name : Pterocarpus marsupium Roxb.Chemical Constituents : Epicatechin, Marsupin, Pterostilbene.Therapeutic Action : Saraka, Vatartidoshanut, Galadoshaghna, Keshya, Tvacya, Raktamandalanalanashini, KaphapitagnaTherapeutic Uses : Pandu, Prameha, Medodosha, Kushta, Krimiroga, Shvitra, Madhumeha, SthoulyaTherapeutic Form and Dose: 32-50 g of the drug for decoctionRECENT STUDIES124: 1. Anti Diabetic activity of Pterocarpus marsupium119. 2. Anti Hyperlipidemic activity of Pterocarpus marsupium119. 3. Hepatoprotective activity of Pterocarpus marsupium119. 4. Cardiotonic activity of Pterocarpus marsupium119. 5. Anti inflammatory activity of Pterocarpus marsupium. 6. Anti oxidant activity of Pterocarpus marsupium119. 7. Insulin like activity of Pterocarpus marsupium119. ‐ 98‐ 
  • 110. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) METHODOLOGY The process of explaining the unexplained facts on the scientific grounds in asystemic and orderly manner can be termed as Research and the scientific methodsadopted to explain the unexplained facts can be termed as the Research Methodology.In the present clinical study, an attempt has been made to explain the Mehagna effect- Anti hyperglycemic effect of a Polyherbal formulation cited in Ayurvedic classics.MATERIALS: For the present clinical study, the Polyherbal formulation selected isVatsakadi Qwatha110 mentioned in Sharangadhara Samhita, Madhyama khanda, 2ndChapter- Qwatha Kalpana Adhyaya- Mehagna context. The ingredients of thePolyherbal formulation includes Vatsaka, Haritaki, Amalaki, Vibhitaki, Daruharidra,Musta and Bijaka.Method of Preparation of Qwatha110: The ingredients of Vatsakadi Qwatha were individually taken in the quantityof 6.5kgs each and made into coarse powder of the seven drugs. To this mixture oftotal 45.5kgs drugs 4 times of water, i.e. 182 ltrs were added and is made to boil onmild fire. It is subjected to fire until it is reduced to 1/4th.The Qwatha thus obtained isfiltered through a Clean Cloth and is collected in a Clean Sterile Container and ismeasured to be 45 litres in quantity. It is then preserved by adding required amount ofMethyl Paraben- to the total quantity of the qwatha obtained. The Qwatha thusprepared is stirred well for uniform dissolution of the preservative and is filled in thebottles of 500ml capacity and is labeled and sealed appropriately. ‐ 99‐   
  • 111. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)METHODSSOURCE OF STUDYa) Literary Source: All available classical references bearing the description of Madhumeha isreferred to obtain the relevant literary data for the study and also all the availableelectronic databases – Pubmed, Webmd and Biomed.b) Pharmaceutical Source: The Polyherbal formulation selected for the present work VatsakadiQwatha is prepared in the pharmacy of A.L.N. Rao Memorial Ayurvedic MedicalCollege as per textual references. It is prepared according to the classical method ofQwatha Kalpana told by Acharya Sharangadhara110.c) Clinical Source: Subjects of either sex diagnosed for Madhumeha on the basis of ClassicalClinical Features are selected from OPD and IPD of A.L.N Rao Ayurveda MedicalCollege and Hospital, Koppa.Sampling Method: Random sampling has been done from the adult population irrespective of sex,religion and economic status satisfying the inclusion criteria.Method of Collection of Data: Based on the classical signs and symptoms of Madhumeha the patients ofeither sex between age group of 25-60 yrs are selected from the OPD and IPD of ALNRao Memorial Ayurveda College Hospital. Totally 30 members of patients is selectedfor study purpose by random sampling method following inclusion and exclusioncriteria. The trial group has been given Vatsakadi Qwatha 50ml twice daily beforefood in divided doses. The duration of the treatment is 45 days. For the purpose of ‐ 100‐   
  • 112. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)assessment, scoring has been given to all signs and symptoms from grade 0-3according to severity and is documented appropriately before the treatment, after 15days, 30 days and 45 days of the treatment and 90 days of follow up withoutmedication with an interval of 15 days. Statistical analysis is done by using pairedStudent‘t’ test. A) Inclusion Criteria123:1. The patients with Prabhutamutrata, Avilamutrata, along with other signs andsymptoms like Pipasa Adhikata, Kshudha Adhikata, Karapada Daha, KarapadaSuptata, Swedapravruthi and Dourbalya is included for the present study.2. Age group between 25123-60yrs of either sex is included for the present study.3. The diabetic patients with Fasting Blood Sugar Level ranging from 126mg/dL-180mg/dL and Post Prandial Blood Sugar level ranging from 160mg/dl - 250mg/dl isincluded for the present study.B) Exclusion Criteria123:1. Age group > 60 yrs and < 25 yrs are excluded.2. Fasting Blood Sugar Level < 126 mg/dl, Post Prandial Blood Sugar Level <140mg/dl.3. Patients suffering with systemic disorders like Renal Disorder, Cardiac disorderetc.4. Sahaja and Jathaja Madhumeha w.s.r to MODY and Gestational diabetes123.5. Patient with diabetic gangrene, carbuncles and other diabetic complications.DIAGNOSTIC CRITERIA123: Patients were diagnosed on the basis of signs and symptoms related toMadhumeha laid down in Ayurvedic Classics and Essential Laboratory Findingsexplained for Diabetes Mellitus. They are given as follows. ‐ 101‐   
  • 113. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)1. Prabhutamutrata 7. Karapada Suptata.2. Avilamutrata 8. Dourbalya.3. Pipasa Adhikata. 9. FBS ≥126mg/dl- 180mg/dl.4. Kshudha Adhikata. 10. PPBS ≥200mg/dl-250mg/dl.5. Swedapravruthi. 11. HBA1C6. Karapada Daha 12. FUS and PPUS.STUDY DESIGN:Standardized Single Blind Clinical Study, done for a group of 20 subjects. TableNo.17 Treatment Schedule Sample size 20 patients Medicine Vatsakadi Qwatha Dose 50ml twice daily before food in divided doses Duration 45 days.FOLLOW UP: The follow up of the study had been done for 90 days withoutmedication.LABORATORY INVESTIGATIONS FBS- Fasting Blood Sugar PPBS- Post Prandial Blood Sugar. FUS – Fasting Urine Sugar. PPUS - Post Prandial Urine Sugar. HBA1c –Glycated/ Glycosalated Hemoglobin ‐ 102‐   
  • 114. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) Diabetic Quality Of Life – Questionaire**Quality of life has gained maximum focus in the recent days especially in the diseaseDiabetes Mellitus and has become an important outcome in any clinical trial andhealthcare interventions. So here an attempt will be made for assessing the DiabeticQuality Of Life (DQOL) by selecting few relevant Questions from DCCT andWHOQOL approved and validated Diabetic Quality Of Life – DQOL Questionaireand Scoring. These Questions related will be assessed before and after the treatmentaccordingly.Sl no. QUESTIONS SCORING I. PHYSICAL 1. How often do you feel physically ill? 1 2 3 4 5 2. How often do you have bad night sleeps? 1 2 3 4 5 3. To what extent do you have difficulty in performing 1 2 3 4 5 your routine activities? 4. How much are you bothered by any limitations in 1 2 3 4 5 performing everyday living activities? 5. How often do you feel fatigue? 1 2 3 4 5 II. PSYCHOSOCIAL 1. How satisfied are you with your social relationship? 1 2 3 4 5 2. How often do you feel good about yourself? 1 2 3 4 5 3. Do you get the kind of support from others that you 1 2 3 4 5 need? 4. How much do you experience positive feelings in your 1 2 3 4 5 life? 5. How well are you able to concentrate? 1 2 3 4 5 III. SEXUAL 1. How often does your diabetes interfere with your sex 1 2 3 4 5 life? 2. How satisfied are you with your sex life? 1 2 3 4 5 ‐ 103‐   
  • 115. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) 3. How often are you worried about your sexual life? 1 2 3 4 5 4. Are you bothered by any difficulties in your sex life? 1 2 3 4 5 5. How well are your sexual needs fulfilled? 1 2 3 4 5 IV. SATISFACTION IN LIFE 1. How satisfied are you with the quality of your life? 1 2 3 4 5 2. How much do difficulties with transport restrict your 1 2 3 4 5 life? 3. To what extent are you hopeful about your life? 1 2 3 4 5 4. To what extent do you feel peaceful within yourself? 1 2 3 4 5 5. To what extent does faith contribute to your well-being? 1 2 3 4 5 V. TREATMENT SATISFACTION 1. How willing are you to take medications? 1 2 3 4 5 2. How much do you need any medication to function in 1 2 3 4 5 your daily life? 3. How dependent are you on medications? 1 2 3 4 5 4. How satisfied are you about the present treatment? 1 2 3 4 5 5. How confident are you with the outcome of the 1 2 3 4 5 treatment? HEALTH PERCEPTION* 1. Compared to others of your age would you say your E G F P VP health is** SOURCE - WHOQOL - SRPB field test instrument and DCCT approved andvalidated Questionaire.* Health Perception – E- excellent, G- good, F – fair, P- poor, VP-Very poor. ‐ 104‐   
  • 116. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) CRITERIA FOR ASSESSMENT OF RESULTS WITH GRADING OF PARAMETERS Table No.18 ASSESSMENT CRITERIA AND GRADING OF THE RESULTS SUBJECTIVE PARAMETERSSL PARAMETER ASSESMENT RANGE SCORENO:1. Prabhuta Mutrata(Polyuria) Amount of Urine: a) Normal 500ml-2500ml 0 b) Slightly increased 2500ml-3000ml 1 c) Increased 3000ml- 3500ml 2 d)Markedly >3500ml 3 Increased Frequency of Urination: a) Normal 3-5 times /day & 0-1 times/ night 0 b) Slightly increased 6-8 times/ day & 1-2 times/ night 1 c) Increased 6-8 times/ day & 3-4 times/ night 2 d)Markedly >8 times/ day & > 5 times/ night 3 Increased2. Avilamutrata a) Normal a)Clearly readable letters 0 b) slightly increased b)Readable letters 1 c) Increased c)Can read with difficulty 2 d)Markedly d)Cannot read the letters 3 Increased3. Pipasa Adhikata a) Normal 1.5-2 ltrs/day intake of water 0 b) Slightly increased 2-3 ltrs/day intake of water 1 c) Increased 3-4 ltrs/day intake of water 2 d)Markedly >4 litters intake of water 3 Increased4. Kshudha Adhikata a) Normal Taking food 2-3 times a day 0 b) Slightly increased Taking food 4-5 times a day 1 c) Increased Taking food 6-7 times a day 2 d)Markedly Taking food >8 times a day 3 Increased5. Swedapravruthi a) Normal Normal sweating by doing normal physical 0 exercise(daily work) b) Slightly increased excessive sweating by doing normal physical 1 exercise(daily work) ‐ 105‐   
  • 117. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) c) Increased excessive sweating even by walking some distance or stepping a ladder 2 (even by mild daily work) d)Markedly Excessive sweating even at rest also. 3 Increased6. Karapada Daha a) Normal Absent 0 b) Slightly increased occasionally mildly present 1 c) Increased constantly mildly present 2 d)Markedly severely present 3 Increased7. Karapada Suptata a) Normal Absent 0 b) Slightly increased occasionally mildly present 1 c) Increased constantly mildly present 2 d)Markedly severely present 3 Increased8. Dourbalya a) Normal can do normal physical exercise(daily work ) 0 without any difficulty b) Slightly increased can do normal physical exercise(daily work 1 )with some difficulty c) Increased can do normal physical exercise(daily work 2 )with much difficulty d)Markedly Cannot do daily activities 3 Increased OBJECTIVE PARAMETERS9 Blood Sugar FASTING BLOOD SUGAR a) Normal 80-126mg/dl 0 b) Slightly increased 126-150mg/dl 1 c) Increased 150-180mg/dl 2 d)Markedly >180mg/dl 3 Increased10 POST PRANDIAL BLOOD SUGAR a) Normal 126-160mg/dl 0 b) Slightly increased 161-190mg/dl 1 c) Increased 190-220mg/dl 2 d)Markedly 221-250mg/dl 3 Increased11 FASTING URINE SUGAR Normal Absence of glucose in urine (No ppt) 0 ‐ 106‐   
  • 118. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) Slightly increased Presence of 0.5% of glucose in urine (Green 1 ppt) Increased Presence of 1 % of glucose in urine (Yellow 2 ppt) Markedly Increased Presence of 1.5% of glucose in urine (Orange 3 ppt) 12 POST PRANDIAL URINE SUGAR Normal Absence of glucose in urine (No ppt) 0 Slightly increased Presence of 0.5% of glucose in urine (Green 1 ppt) Increased Presence of 1 % of glucose in urine (Yellow 2 ppt) Markedly Increased Presence of 1.5% of glucose in urine (Orange 3 ppt) 13 GLYCATED / GLYCOSALATED HEMOGLOBIN – HBA1C Normal <8% 0 Good control 8-9% 1 Fair control 9-10% 2 Poor control >10% 3 12 DIABETIC QUALITY OF LIFE Not at all 1 A little 2 Moderate amount 3 Very much 4 Extreme amount 5 OVERALL ASSESSMENT CRITERIA The overall effect of the therapy was assessed as stated below.1. A patient in whom there was reduction in the assessment criteria to grade 0 against the initial severity scoring is considered as 90%-100% response. It is considered as good response.2. Patient in whom there was reduction in 2 levels of the assessment criteria against the initial severity scoring is taken as 60%-90% response. It is taken as marked response.3. Patient in whom there was reduction in one level of the assessment criteria against the initial severity scoring is taken as 30%-60% response. It is taken as mild response. ‐ 107‐   
  • 119. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)4. Patients in whom assessment criteria remained same against the initial severity scoring is taken as 0-30% response and is considered as poor response. OVERALL ASSESSMENT CRITERIA Table No. 19 Overall Assessment Criteria Percentage of cure Interpretation 76-100% Good Response 50-75% Moderate Response 26-49% Mild Response 0- 25% Poor Response STATISTICAL ANALYSIS: Here the effect of drug administration has been critically analyzed by the statistical data. Descriptive Statistical Data which includes Mean, Standard Deviation (S.D), Standard Error (S.E), t- value and P- value were calculated for all the variables. Post-therapeutic effect of the administered drug is assessed by paired student‘t’ test. For all the tests, a ‘P’ value of < 0.05 is considered as the statistical significance level for obtaining accurate result. ‐ 108‐   
  • 120. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) OBSERVATION In this present clinical study, 30 subjects were enrolled. Among the 30subjects enrolled, 5 subjects were excluded from the study based on the exclusioncriteria. Among rest of 25 subjects who fulfilled the inclusion criteria were taken forthe study, out of which 5 subjects were discontinued during various stages of thetreatment. Finally only 20 subjects who completed the full course of treatment withfollow up observation were taken for observation and statistical analysis. Followingpages contain the descriptive observational analysis of the subjects. Theseobservations are compiled under the following heading. A. Demographic Data of the Study. B. Clinical Data of the Study. C. Data related to the Diabetic Quality Of Life. D. Data Related to Results of the Study. A. DEMOGRAPHIC DATA1. Data showing Agewise Distribution of the 20 subjects. Table No: 20 Agewise Distribution of the 20 subjects. AGE RANGE No. OF SUBJECTS PERCENTAGE 25-30 00 0% 31-35 01 05% 36-40 04 20% 41-45 07 35% 46-50 00 00% 51-55 04 20% 56-60 04 20% ‐ 110‐   
  • 121. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Majority of the subjects were between the age range 41-45 i.e about 07subjects among the 20 subjects accounting for 35% of the total observation. Betweenthe age ranges 36-40, 51-55 and 56-60; about 04 subjects in each ranges accountingfor 20% in each of the total observation were observed. Only one subject was foundbetween the age group of 31-35, which accounts for about 5% of the total observation.Chart No: 4 Agewise Distribution Chart No: 5 Sexwise Distribution2. Data Showing Sexwise Distribution of the 20 Subjects. Table No: 21 Sexwise Distribution of the 20 subjects. Sex Number Percentage Males 05 25% Females 15 75% Majority of the subjects were female’s i.e about 15 subjects among the 20subjects taken for the study accounting for about 75% of the total observation.Remaining 05 subjects were male, accounting for about 25% of the total observation. ‐ 111‐   
  • 122. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)3. Data of Religoinwise Distribution of 20 subjects. Table No: 22 Religoinwise Distribution of 20 subjects. RELIGION NUMBER PERCENTAGE Hindu 14 70% Muslim 06 30% In the present study, 70% i.e about 14 of the 20 subjects were Hindus andremaining 15% i.e about 06 subjects were Muslims.Chart No: 6 Religoinwise Chart No: 7 Educationwise Distribution Distribution4. Distribution of Educational Qualifications of the 20 subjects. Table No: 23 Educationwise Distributions of the 20 Subjects. EDUCATION NO OF SUBJECTS PERCENTAGE Primary level 03 15% Secondary level 04 20% High school level 04 20% Graduate level 07 35% Illiterate 02 10% It is observed that 35% of the total observation i.e 8 subjects of the 20 subjectshad the education at Graduate Level, 20% each i.e 4 subjects each from the 20subjects were educated to the level of Secondary and High School Level, 15% i.e 03 ‐ 112‐   
  • 123. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)subjects of the 20 subjects were educated to the Primary Level and remaining 10% i.e02 subjects of the 20 subjects were Illiterates.Chart No: 8 Marital Statuswise Chart No: 9 Occupationwise5. Data of Marital Statuswise Distributions of the 20 Subjects. Table No: 24 Marital Statuswise Distributions of the 20 Subjects. MARITAL STATUS NO OF SUBJECTS PERCENTAGE Married 17 85% Single 03 15% In the present study, 85% i.e 17 of the 20 subjects were Married andremaining 15% i.e 03 subjects were unmarried or single.6. Data related to Occupationwise Distribution of the 20 Subjects. In the present study, 55% i.e 11 subjects were homemakers, 20% i.e 04subjects were teachers, 10% i.e 02 subjects were officials and remaining were equallydistributed with 5% i.e 01 subjects each were Watchman, Attender, and Engineerrespectively. ‐ 113‐   
  • 124. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) OCCUPATION NO OF SUBJECTS PERCENTAGE Homemaker 11 55% Teacher 04 20% Officer 02 10% Watchman 01 5% Attender 01 5% Engineer 01 5% Table No: 25 Occupationwise Distributions.7. Data related to habitat distributions of the 20 subjects. Table No: 26 Percentage of distribution of Habitat. HABITAT NO OF SUBJECTS PERCENTAGE Urban 08 40 Rural 12 60 In the present study, 60% i.e 12 subjects of the 20 subjects were among Ruralpopulation and remaining 40% i.e 08 subjects were among Urban population.Chart No: 10 Habitatwise. Chart No: 11 Socioeconomic Statuses. ‐ 114‐   
  • 125. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)8. Data Related to the Socio Economic Status of the 20 Subjects. Table No: 27 Distribution of Socio economic Status of the 20 Subjects. SOCIOECONOMIC STATUS NO OF SUBJECTS PERCENTAGE Higher income group 01 5% Middle income group 14 70% Low income group 05 25% In the present study, 70% i.e 14 subjects of the 20 subjects were from MiddleIncome Group, 25% i.e 05 subjects were from Low Income Group and remaining 5%i.e one subject was from High Income Group.9. Distribution of Desapradhanatha Table No: 28 Distribution of Desapradhanatha DESA NUMBER PERCENTAGE Sadharana 4 20 Anupa 16 80% In the present study, 80% i.e 16 subjects of the 20 subjects were residing inJangaladesa and remaining 20% i.e 04 subjects were residing in Sadharanadesha. Chart No: 12 Percentage of Desapradhanatha ‐ 115‐   
  • 126. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) B.SUBJECT’S CLINICAL DATA1. Data Related to Chief Complaints. Table No: 29 Data Related to Chief Complaints. CHIEF COMPLAINTS NO. OF SUBJECTS PERCENTAGE Frequency 16 80% Prabhutmutrata Amount 16 80% Avila Mutrata 20 100% Pipasa Adhikata 14 70% Kshudha Adhikata 10 50% Sweda Pravruthi Adhikata 17 85% Karapadathaladaha 19 95% Karapadathalasupti 17 85% Dourbalya 20 100% In the present study, 100% i.e 20 out of 20 subjects had Avila Mutrata (AM)and Dourbalya (D), 95% i.e 19 out of 20 subjects had Karapadadaha (KD), 85% i.e 17out of 20 subjects had Sweda Pravruthi Adhikata (SP) and Karapadasupti (KS), 80%i.e 16 out of 20 subjects had Prabhutamutrata (PM), 70% i.e 14 out of 20 subjects hadPipasa Adhikata (PA) and 50 % i.e 10 out of 20 subjects had Kshudha Adhikata (KA)as their Chief Complaints. ‐ 116‐   
  • 127. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)2. Data Related to the History of Present Illness: In the present study, it was found that 45% i.e 9 out of 20 subjects wereaccidentally diagnosed with the complaint of Pruritis vulvae while remaining 55%were diagnosed with the classical symptoms of Madhumeha.3. Data Related to the History of Past Illness: In the present study, it was found that 40% i.e 8 out of 20 subjects were havingthe previous history of cold, cough and fever in common4. Data related to Family History. Table No: 30 Data related to Family History. FAMILY HISTORY NO OF SUBJECTS PERCENTAGE Present 00 0% Absent 20 100% In the present study, 100% i.e 20 out of 20 subjects showed no family history.Chart No: 14 Data on Family History Chart No: 15 Data on Diet ‐ 117‐   
  • 128. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)5. Data related to Personal History:a) Data related to Dietary regimen. Table No: 31 Data related to Dietary regimen. Dietary Regimen No of subjects Percentage Untimely Vegetarian 11 55% Untimely Mixed 9 45% In the present study, 55% i.e 11 out of 20 subjects were having UntimelyVegetarian Dietary Regimen and remaining 45% i.e 9 out of 20 subjects wereobserved to have Untimely Mixed Dietary Regimen.b) Data related to Supplementary Diet Table No: 32 Data related to Supplementary Diet Supplementary diet No of subjects Percentage Tea 8 40% Coffee 10 50% Milk 2 10% Cool drinks 3 15% Junks/Chats 10 50% In the present study, 8 subjects i.e 40% had the habit of taking tea, 10subjects i.e 50% had the habit of taking coffee, 2 subjects i.e 10% had the habit oftaking milk, 3 subjects i.e 15% had the habit of taking cool drinks and 10 subjects i.e50% had the habit of taking junks / chats. ‐ 118‐   
  • 129. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Chart no.16 Data on Supplementary Diet Chart no.17 Data on Nidrac) Data related to Nidra Table No: 32 Data related to Nidra Nidra No of subjects Percentage Disturbed 10 50% Undisturbed 10 50% In the present study, 10 of 20 subjects i.e 50% had disturbed sleep andanother 10 of 20 subjects i.e 50% had undisturbed sleep.4. Data related to General Examination:a) Data related to Body Mass Index Table No: 32 Data related to Body Mass Index BMI No of subjects Percentage 19-23 ( Normal) 17 85% 23-27(Over Weight) 02 10% 27-31(Obese) 01 05% 31-35(Very Obese) 00 0% In the present study, 85% i.e 17 out of 20 subjects were observed to havenormal body mass index while 10% i.e 2 subjects were observed to fall under overweight and only 05% i.e one out of 20 subjects was observed to fall under the obese. ‐ 119‐   
  • 130. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)Chart no.18 Data related to BMI Chart no.19 Data on Blood Pressureb) Data Related To Blood Pressure: Table no.33 Data Related To Blood Pressure NO. of BLOOD PRESSURE PERCENTAGE SUBJECTS 110/70 mm of Hg 07 35% 120/80 mm of Hg 07 35% 130/90 mm of Hg 06 30% In the present study, 35% i.e 07 out of 20 subjects were observed tohave shared equally with 110/70 mm of Hg and 120/80 mm of Hg, while 30% i.e 06subjects out of 20 subjects were observed to 130/90 mm of Hg.c) Data Related To the Mean Biochemical Values Table No: 38 Data related Mean Biochemical Values Biochemical tests Mean values FBS 176mg/dl PPBS 226mg/dl HBA1C 8.2% ‐ 120‐   
  • 131. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)5. Data related to Ashtasthana Pareeksha:a) Data related to Nadi Table No: 38 Data related to Nadi Nadi No of subjects Percentage Vatapitaja 10 50% Drutha 07 35% Manda 4 20% In the present study, Sadharana nadi was observed for 50% i.e in 10 subjects.Drutha was observed for 35% i.e 07 subjects out of 20 and finally Manda nadi wasobserved for 20% i.e. 04 subjects out of 20 subjects.b) Data related to Mutra: In the present study, 80% i.e 16 subjects of the 20 subjects were observedto have Prabhootamootrata and 100% i.e 20 subjects out of 20 subjects were observedto have Avilamutrata and there was no burning Micturition and other systemic relatedClinical features but it was also observed that 05 subjects out of 20 subjects who hadAvilamutrata had sticky and foul odour and remaining 16 subjects were observed tohave aggravated Pruritis vulvae especially after micturition.c) Data related to Mala: In the present study, 80% i.e 16 subjects of the 20 subjects were observedto have irregular bowel habit with easy evacuation but, remaining 20% i.e 04 out of20 subjects were observed to have irregular bowel habit with difficulty in evacuationand hard stools. ‐ 121‐   
  • 132. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)d) Data related to Jihwa: In the present study, 80% i.e 16 subjects of the 20 subjects were observedto have dryness of the tongue along with 45% i.e 09 subjects out of 20 subjects wereobserved to have whitish coating over the tongue.e) Data related to Sabda: No abnormalities in the Sabda have been observed in any subject.f) Data related to Sparsa: Table No: 39 Data related to Sparsa: Sparsa No of subjects Percentage Ushna 16 80% Sheeta 04 20%g) Data related to Druk: In the present study, none of the subjects were observed to have pallor andother visual defects.h) Data related to Akruthi: Table No: 40 Data related to Akruthi: AKRUTHI No of SUBJECTS PERCENTAGE Pravaram 02 10% Madhyamam 18 90% Avaram 00 00%In the present study, 18 subjects i.e 90% showed Madhyama Akruthi and only 2subjects i.e 10% showed Pravara Akruthi. ‐ 122‐   
  • 133. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)6) Data related to Dasavidha Pareeksha:a) Data related to Prakruthi Table No: 41 Data related to Prakruthi Prakruthi No of subjects Percentage Pithakapha 01 05% Kaphavata 02 10% Vatapita 05 25% Kaphapita 05 25% Vatakapha 07 35% Pitavata 00 00% In the present study, Pitakapha was observed in 05% i.e 01 out of 20 subjects,Kaphavata was observed in 10% i.e 02 out of 20 subjects, Vatapita was observed in25% i.e 05 out of 20 subjects, Kaphapita was observed in 25% i.e 05 out of 20subjects, Vatakapha was observed in 35% i.e 07 out of 20 subjects, Pitavata wereobserved nil among the 20 subjects.b) Data related to Vikruthi: Table No: 42 Data related to Vikruthi: Vikruthi involved No of subjects PercentageRasa 20 100%Medas 20 100%Raktha 17 85%Mamsa 18 90%Majja 10 50%Sukra 09 45%Kleda 20 100%Lasika 20 100%Oja 10 50% ‐ 123‐   
  • 134. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) In the present study, Rasa, Medas, Kleda and Lasika dushti was observed in100% of the subjects. Majja and Ojo dushti was observed in 50% of the subjects.Raktha Dushti was observed in 85% of subjects. Mamsa Dushti was observed in 90%of the subjects and Shukra Dushti was observed in 45% of the subjects.c) Data related to Satvataha: In the present study, 85% i.e 17 subjects out of 20 were observed to haveMadhyama Satva and 15% i.e 03 subjects out of 20 were observed to have AvaraSatva.d) Data related to Satmyatha: In the present study, 80% i.e 16 subjects out of 20 were observed to haveMadhyama Satmyata and 20% i.e 04 subjects out of 20 were observed to have AvaraSatmyata.e) Data related to Ahara Shakthitaha: In the present study, 50% of the subjects were observed to have MadhyamaAhara shakti while remaining 50% were observed for Pravara Ahara shakti.f) Data related to Vyayama Shakthitaha: Table No: 43 Data related to Vyayama Shakthitaha: Vyayamasakthi Number of subjects. Percentage Pravaram 02 10% Madhyamam 16 80% Avaram 02 10% In the present study only 2 subjects each showed Pravara and Avara vyayamashakti while remaining dominated with Madhyama vyayama shakti i.e 16 subjects ‐ 124‐   
  • 135. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)g) Data related to Vaya Table No: 44 Data related to Vaya: Age No of subjects Percentage Balyavastha 00 00 Madhyamavastha 16 80% Vrudhavastha 04 20% In the present study 80% i.e 16 subjects out of 20 were observed to be inMadhyamavastha and 20% i.e 04 subjects out of 20 were observed to be inVrudhavastha.7). Data related to Nidana: Table No: 45 Data related to Nidana: Nidana No of subjects PercentageAsyasukham 20 100%Swapnasukham 20 100%Carbohydrate rich diet 20 100%Fat rich diet 20 100%Manasika Nidana 20 100%Lack of exercise 20 100% In the present study, Asyasukham- in terms of taking excessive sweet and itsby products, Swapnasukham – in terms of sedentary lifestyles, intake of carbohydrate- Rice, Jaggery and Grains, while fat rich dietary items like curd, butter and nonvegetarian food items was observed in all the subjects. It was also observed for vihara like sedentary sitting and sexual habits alongwith lack of exercise in 100% i.e 20 subjects out of 20 subjects. Chintashokadodvegadi Manasika Nidana was also observed in 100% i.e 20 subjects out of20 subjects. ‐ 125‐   
  • 136. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)9) Data related to Purvarupa: Table No: 47 Data related to Purvarupa: Purvarupa No of subjects PercentageKarapadathaladaha 19 95%Pipasa 17 85%Dantamalam 18 90%Nayanamalam 08 40%Karnamalam 02 10%Alasyam 19 95%Shareera Dourgandhyam 12 60%Athitandra 15 75%Athinidra 15 75%Karapadathalasupti 15 75%Kesheshu Jatilibhava 02 10%Asyamadhuryam 02 10% In the present study, Karapadadaha and Alasya was observed as a purvarupafor 19 subjects (95%), Dantamalam for 18 subjects (90%), Pipasa for 17% (85%),Athinidra, Athitandra and Karapadatala Supti for 15 subjects (75%), Nayanamalamfor 08 subjects (40%), Shareera Dourgandhyam for 12 subjects (60%), KesheshuJatilibhava and Asyamadhuryam was observed in 02 subjects (10%).10) Data Related To Upashaya: Table no. Data Related To Upashaya Upashaya No of subjects Percentage Nimba Patra 20 100% Guduchi Patra 20 100% Menthe Powder 20 100% Walking 19 100% Exercise 19 100% Yoga 02 10% ‐ 126‐   
  • 137. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)11) Data Related To Sroto Dushti: Table no. Data Related To Sroto Dushti Sroto dushti No of subjects Percentage Rasavaha 20 100% Raktavaha 19 95% Medovaha 18 90% Udakavaha 14 70% Annavaha 10 50% Mutravaha 16 80%C. Data Related To Diabetic Quality Of Life: Table no. Data Related To Diabetic Quality Of Life Questions Affected No of subjects Percentage Physical 20 100% Psychosocial 10 50% Sexual 18 90% Life satisfaction 14 70% Treatment satisfaction 10 50% Health perception 16 80% ‐ 127‐   
  • 138. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) RESULTS EFFECT OF VATSAKADI QWATHAON MADHUMEHA The Statistical analysis over the effect of Vatsakadi Qwatha after 15,30,and 45days of treatment period and 90 days of follow-up period are hereby calculated usingpaired Student‘t’ test. The statistical analytical reports are as follows, Effect of Vatsakadi Qwatha on Subjective Parameters1. Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased amount ofurination)Table No: 48 Effect of Vatsakadi Qwatha on Prabhutamutrata (Increasedamount of urination) MeanNo Data % S.D S.E T P BT AT 1. AT 15 days 1.60 1.30 18.75 0.22 0.10 2.78 <0.02 2. AT 30 days 1.60 0.90 41.92 0.22 0.10 6.48 <0.001 3. AT 45 days 1.60 0.60 61.29 0.57 0.17 5.45 <0.001 4. AFU-90 days 1.60 0.90 38.70 0.46 0.15 3.84 <0.01 Vatsakadi Qwatha provided mild significant (P<0.02) relief by 18.75% in thesymptom Prabhuta mutrata (amount of urine) after 15 days of treatment. VatsakadiQwatha provided highly significant (P<0.001) relief by 41.92% in the symptomPrabhuta mutrata (amount of urine) after 30 days of treatment. Vatsakadi Qwathaprovided highly significant (P<0.001) relief by 61.29% in the symptom Prabhutamutrata (amount of urine) after 45 days of treatment. Vatsakadi Qwatha providedmoderately significant (P<0.01) relief by 38.70% in the symptom Prabhuta mutrata(amount of urine) after 90 days follow-up period. ‐ 128-  
  • 139. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)2. Effect of Vatsakadi Qwatha on Prabhutamutrata (Increased frequency ofurination)Table No: 49 Effect of Vatsakadi Qwatha on Prabhutamutrata (Increasedfrequency of urination) Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.70 1.35 20.58 0.23 0.11 3.13 <0.02 2. AT 30 days 1.70 0.95 44.11 0.19 0.10 7.35 <0.001 3. AT 45 days 1.70 0.40 76.47 0.64 0.18 7.07 <0.001 4. AFU-90 days 1.70 1.05 38.82 0.55 0.17 3.80 <0.01 Vatsakadi Qwatha provided mild significant (P<0.02) relief by 20.58% in thesymptom Prabhuta mutrata (frequency) after 15 days of treatment. Vatsakadi Qwathaprovided highly significant (P<0.001) relief by 44.11% in the symptom Prabhutamutrata (frequency) after 30 days of treatment. Vatsakadi Qwatha provided highlysignificant (P<0.001) relief by 76.47% in the symptom Prabhuta mutrata (frequency)after 45 days of treatment. Vatsakadi Qwatha provided moderately significant(P<0.01) relief by 38.82% in the symptom Prabhuta mutrata (frequency) after 90 daysfollow-up period.3. Effect of Vatsakadi Qwatha on Avila Mutrata Table No: 50 Effect Of Vatsakadi Qwatha on Avila Mutrata Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.80 1.50 16.66 0.22 0.10 2.78 <0.02 2. AT 30 days 1.80 0.95 47.22 0.55 0.17 4.97 <0.001 3. AT 45 days 1.80 0.50 72.22 0.43 0.15 8.62 <0.001 4. AFU-90 days 1.80 1.30 27.77 0.26 0.11 4.24 <0.001 ‐ 129-  
  • 140. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Vatsakadi Qwatha provided mild significant (P<0.02) relief by 16.66% in thesymptom Avila mutrata after 15 days of treatment. Vatsakadi Qwatha providedhighly significant (P<0.001) relief by 47.22% in the symptom Avila mutrata after 30days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by72.22% in the symptom Avila mutrata after 45 days of treatment. Vatsakadi Qwathaprovided highly significant (P<0.001) relief by 27.77% in the symptom Avila mutrataafter 90 days follow-up period.4. Effect of Vatsakadi Qwatha on Pipasa Adhikata Table No: 51 Effect Of Vatsakadi Qwatha on Pipasa Adhikata Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.05 0.80 23.08 0.40 0.14 1.70 <0.05 2. AT 30 days 1.05 0.35 66.06 0.85 0.21 3.30 <0.01 3. AT 45 days 1.05 0.30 71.42 0.72 0.19 3.84 <0.01 4. AFU-90 days 1.05 0.45 57.14 0.67 0.18 3.18 <0.01 Vatsakadi Qwatha provided significant (P<0.05) relief by 23.08% in thesymptom Pipasa Adhikata after 15 days of treatment. Vatsakadi Qwatha providedmoderately significant (P<0.01) relief by 66.06% in the symptom Pipasa Adhikataafter 30 days of treatment. Vatsakadi Qwatha provided moderately significant(P<0.01) relief by 71.42% in the symptom Pipasa Adhikata after 45 days of treatment.Vatsakadi Qwatha provided moderately significant (P<0.01) relief by 27.77% in thesymptom Pipasa Adhikata after 90 days follow-up period. ‐ 130-  
  • 141. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)5. Effect of Vatsakadi Qwatha on Kshudha Adhikata Table No: 52 Effect of Vatsakadi Qwatha on Kshudha Adhikata Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 0.70 0.50 28.57 0.16 0.09 2.12 <0.05 2. AT 30 days 0.70 0.25 64.28 0.47 0.15 2.85 <0.02 3. AT 45 days 0.70 0.25 85.71 0.46 0.15 3.84 <0.01 4. AFU-90 days 0.70 0.30 57.14 0.35 0.13 2.91 <0.01 Vatsakadi Qwatha provided significant (P<0.05) relief by 28.57% in thesymptom Kshudha Adhikata after 15 days of treatment. Vatsakadi Qwatha providedmild significant (P<0.02) relief by 64.28% in the symptom Kshudha Adhikata after 30days of treatment. Vatsakadi Qwatha provided moderately significant (P<0.01) reliefby 85.71% in the symptom Kshudha Adhikata after 45 days of treatment. VatsakadiQwatha provided moderately significant (P<0.01) relief by 57.14% in the symptomKshudha Adhikata after 90 days follow-up period.6. Effect of Vatsakadi Qwatha on Sweda-Pravruthi Table No: 53 Effect of Vatsakadi Qwatha on Sweda Pravruthi Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.30 1.20 7.69 0.094 0.07 1.41 <0.05 2. AT 30 days 1.30 0.70 46.15 0.35 0.13 4.37 <0.001 3. AT 45 days 1.30 0.45 66.38 0.66 0.18 4.55 <0.001 4. AFU-90 days 1.30 0.60 53.84 0.32 0.13 5.34 <0.001 ‐ 131-  
  • 142. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Vatsakadi Qwatha provided significant (P<0.05) relief by 7.69% in thesymptom Sweda Pravruthi after 15 days of treatment. Vatsakadi Qwatha providedhighly significant (P<0.001) relief by 46.15% in the symptom Sweda Pravruthi after30 days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) reliefby 85.71% in the symptom Sweda Pravruthi after 45 days of treatment. VatsakadiQwatha provided highly significant (P<0.001) relief by 53.84% in the symptomSweda Pravruthi after 90 days follow-up period.7. Effect of Vatsakadi Qwatha on Karapada Daha Table No: 54 Effect of Vatsakadi Qwatha on Karapada Daha Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.40 1.10 21.40 0.22 0.10 2.78 >0.05 2. AT 30 days 1.40 0.45 67.85 0.15 0.09 10.50 <0.001 3. AT 45 days 1.40 0.25 82.14 0.34 0.13 8.53 <0.001 4. AFU-90 days 1.40 0.65 53.57 0.30 0.12 5.94 <0.001 Vatsakadi Qwatha provided significant (P<0.05) relief by 21.40% in thesymptom Karapada Daha after 15 days of treatment. Vatsakadi Qwatha providedhighly significant (P<0.001) relief by 67.85% in the symptom Karapada Daha after 30days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by82.14% in the symptom Karapada Daha after 45 days of treatment. VatsakadiQwatha provided highly significant (P<0.001) relief by 53.57% in the symptomKarapada Daha after 90 days follow-up period. ‐ 132-  
  • 143. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)8. Effect of Vatsakadi Qwatha on Karapada Suptata Table No: 55 Effect of Vatsakadi Qwatha on Karapada Suptata Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 0.90 0.80 11.11 0.09 0.070 1.41 <0.05 2. AT 30 days 0.90 0.45 32.14 0.36 0.13 3.24 <0.02 3. AT 45 days 0.90 0.25 46.42 0.45 0.15 4.22 <0.001 4. AFU-90 days 0.90 0.35 39.28 0.26 0.11 4.69 <0.001 Vatsakadi Qwatha provided significant (P<0.05) relief by 11.11% in thesymptom Karapada Suptata after 15 days of treatment. Vatsakadi Qwatha providedmild significant (P<0.02) relief by 32.14% in the symptom Karapada Suptata after 30days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by46.42% in the symptom Karapada Suptata after 45 days of treatment. VatsakadiQwatha provided highly significant (P<0.001) relief by 39.28% in the symptomKarapada Suptata after 90 days follow-up period.9. Effect of Vatsakadi Qwatha on Dourbalya Table No: 56 Effect of Vatsakadi Qwatha on Dourbalya Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.55 1.30 16.12 0.19 0.10 2.45 <0.05 2. AT 30 days 1.55 0.20 87.09 0.23 0.11 12.02 <0.001 3. AT 45 days 1.55 0.15 90.32 0.56 0.17 8.09 <0.001 4. AFU-90 days 1.55 0.70 54.85 0.55 0.17 4.97 <0.001 ‐ 133-  
  • 144. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Vatsakadi Qwatha provided significant (P<0.05) relief by 16.12% in thesymptom Dourbalya after 15 days of treatment. Vatsakadi Qwatha provided highlysignificant (P<0.001) relief by 87.09% in the symptom Dourbalya after 30 days oftreatment. Vatsakadi Qwatha provided highly significant (P<0.001) relief by 90.32%in the symptom Dourbalya after 45 days of treatment. Vatsakadi Qwatha providedhighly significant (P<0.001) relief by 54.85% in the symptom Dourbalya after 90 daysfollow-up period. Effect of Vatsakadi Qwatha on Objective Parameters1. Effect of Vatsakadi Qwatha on Fasting Blood Sugar: Table No: 57 Effect of Vatsakadi Qwatha on Fasting Blood Sugar Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.80 1.50 17.64 0.22 0.10 2.78 <0.05 2. AT 30 days 1.80 0.55 67.64 0.30 0.12 9.90 <0.001 3. AT 45 days 1.80 0.15 83.33 0.26 0.11 12.74 <0.001 4. AFU-90 days 1.80 0.65 63.88 0.34 0.13 8.5 <0.001 Vatsakadi Qwatha provided significant (P<0.05) change by 17.64% in FastingBlood Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided highlysignificant (P<0.001) change by 67.64% in Fasting Blood Sugar Level after 30 daysof treatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by83.33% in Fasting Blood Sugar Level after 45 days of treatment. Vatsakadi Qwathaprovided highly significant (P<0.001) change by 63.88% in Fasting Blood SugarLevel after 90 days follow-up period. ‐ 134-  
  • 145. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)2. Effect of Vatsakadi Qwatha on Post Prandial Blood Sugar Table No: 58 Effect of Vatsakadi Qwatha on Post Prandial Blood Sugar Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 1.90 1.60 15.78 0.22 0.10 2.78 >0.02 2. AT 30 days 1.90 0.80 57.89 0.09 0.07 15.57 <0.001 3. AT 45 days 1.90 0.15 89.47 0.43 0.15 11.27 <0.001 4. AFU-90 days 1.90 0.65 65.78 0.40 0.14 8.52 <0.001 Vatsakadi Qwatha provided mild significant (P<0.05) change by 15.78% inPost Prandial Blood Sugar Level after 15 days of treatment. Vatsakadi Qwathaprovided highly significant (P<0.001) change by 57.89% in Post Prandial BloodSugar Level after 30 days of treatment. Vatsakadi Qwatha provided highly significant(P<0.001) change by 89.47% in Post Prandial Blood Sugar Level after 45 days oftreatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by65.78% in Post Prandial Blood Sugar Level after 90 days follow-up period.3. Effect of Vatsakadi Qwatha on Fasting Urine Sugar: Table No: 59 Effect of Vatsakadi Qwatha on Fasting Urine Sugar Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 0.65 0.50 23.07 0.13 0.08 1.78 <0.05 2. AT 30 days 0.65 0.15 76.90 0.47 0.15 3.16 <0.01 3. AT 45 days 0.65 0.15 84.67 0.36 0.13 3.96 <0.001 4. AFU-90 days 0.65 0.40 38.46 0.30 0.12 1.98 <0.05 ‐ 135-  
  • 146. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) Vatsakadi Qwatha provided significant (P<0.05) change by 23.07% in FastingUrine Sugar Level after 15 days of treatment. Vatsakadi Qwatha provided moderatelysignificant (P<0.01) change by 76.90% in Fasting Urine Sugar Level after 30 days oftreatment. Vatsakadi Qwatha provided highly significant (P<0.001) change by84.67% in Fasting Urine Sugar Level after 45 days of treatment. Vatsakadi Qwathaprovided significant (P<0.001) change by 38.46% in Fasting Urine Sugar Level after90 days follow-up period.4. Effect of Vatsakadi Qwatha on Post Prandial Urine Sugar Table No: 60 Effect of Vatsakadi Qwatha on Post Prandial Urine Sugar Mean No. Data % S.D S.E T P BT AT 1. AT 15 days 0.70 0.60 14.28 0.09 0.07 1.41 <0.05 2. AT 30 days 0.70 0.25 64.28 0.47 0.15 2.85 <0.01 3. AT 45 days 0.70 0.15 85.71 0.25 0.11 5.20 <0.001 4. AFU-90 days 0.70 0.30 57.14 0.35 0.13 2.91 <0.01 Vatsakadi Qwatha provided significant (P<0.05) change by 14.28% in PostPrandial Urine Sugar Level after 15 days of treatment. Vatsakadi Qwatha providedmild significant (P<0.02) change by 64.28% in Post Prandial Urine Sugar Level after30 days of treatment. Vatsakadi Qwatha provided highly significant (P<0.001) changeby 85.71% in Post Prandial Urine Sugar Level after 45 days of treatment. VatsakadiQwatha provided moderately significant (P<0.01) change by 57.14% in Post PrandialUrine Sugar Level after 90 days follow-up period. ‐ 136-  
  • 147. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)4. Effect of Vatsakadi Qwatha on HBA1C Table No: 61 Effect of Vatsakadi Qwatha on HBA1C Mean No. Data % S.D S.E T P BT AT 1. HBA1C 0.70 0.65 7.14 0.15 0.09 0.55 <0.05 Vatsakadi Qwatha provided significant change (P<0.05) by 7.14% in theobjective parameter HBA1C.5. Effect of Vatsakadi Qwatha on DQOL: Vatsakadi Qwatha provided remarkable compliance with higher Quality OfLife in Physical (100%), Sexual (90%), Treatment Satisfaction (50%) and in HealthPerception which was remarkably changed in 50% of the subjects from fair toexcellent score even after the follow up period. Although; good compliance was observed after the duration of treatment inPsychosocial (50%) and Life Satisfaction (40%) along with the above aspects ofQOL, it showed moderately poor compliance after the Follow Up period.6. Overall Effect of Vatsakadi Qwatha After 45 days of Treatment. Table no.62 Overall Effect at 90 days Follow Up period CRITERIA No. of patients Percentage GOOD RESPONSE 10 50% MODERATE RESPONSE 04 20% MILD RESPONSE 04 20% POOR RESPONSE 02 10%The overall effect of the investigational product Vatsakadi Qwatha showed goodresponse in 10 subjects i.e 50%, moderate response in 04 subjects i.e 20%, mild ‐ 137-  
  • 148. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)response in 04 subjects i.e 20% and poor response in 02 subjects i.e 10% after 45 daysof treatment period.7. Overall Effect of Vatsakadi Qwatha After 90 days Follow Up Period Table no. 63. Overall Effect at 90 days Follow Up period CRITERIA No. of patients Percentage GOOD RESPONSE 02 10% MODERATE RESPONSE 04 20% MILD RESPONSE 08 40% POOR RESPONSE 06 30% The overall effect of the investigational product Vatsakadi Qwatha showedGood Response in only 02 subject’s i.e 10%, Moderate Response in 04 subjects i.e20%, Mild Response in 08 subjects i.e 40% and Poor Response in 06 subjects i.e 30%after 90 days of Follow Up Period.Chart no.21. Overall Effect of Vatsakadi Qwatha after 45 days of Treatment and 90 days Follow Up period. ‐ 138-  
  • 149. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  DISCUSSION The present 21st century has gradually and drastically changed the attitude ofevery individuals of the` society towards every aspects of life by guiding andprompting them towards a weird quality of day to day physical and mental activitiesand finally making them to lead an obsessive and erratic lifestyle, which in turn hasled to an health crisis of various lifestyle disorders. One among those topmost lifestyledisorders is Madhumeha, which has becoming a major health threat in both developedand developing countries. Although a number of studies had been conducted onMadhumeha with many formulations, still early diagnosis of this iceberg disease hasfound maximum focus in the recent days due to its high incidence as an etiology incardiac deaths123, 121. It also has now become an important outcome of various clinical trials andhealth care interventions as the study expectancy has been aimed at reducing theprevalence and incidence rate of the same with early diagnosis121. At the same time;timely intervention helps in preventing both short- term and long term complicationswhich especially has been the long term aim in the treatment of type-2 diabetes126.The role of psychological factors in triggering the hyperglycemic condition has beenwell established based on the HPA axis dysfunction through various stressors- thedisease identity of the present era121. The present study has been selected not only onthe basis of understanding the need of an effective formulation for effectivemanagement of the condition Madhumeha, but also to understand the importance ofPurvarupa especially in this latter condition based on the Vikara VighataBhavaabhava Prativishesha, which is the guiding tool for the early diagnosis of thesame19. So, discussion on the entire study on various observational and statisticalanalytical data is summarized here after. The strategy for the discussion is as follows, ‐ 139‐   
  • 150. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  1. Discussion on Review of Literature. 2. Discussion on Materials and Method. 3. Discussion on Demographic Data. 4. Discussion on Clinical Data. 5. Discussion on Diabetic Quality Of Life. 6. Discussion on Probable Mode of Action of Vatsakadi Qwatha. DISCUSSION ON REVIEW OF LITERATUREDiscussion on Nirukthi: Literally, the meaning of the words Madhumeha andDiabetes mellitus have many similarities, where both are used with the sense ofperfuse (watering). Regarding the usage of the term Madhumeha, AcharyaChakrapani opines that just like a heap of grass, Truna Samuha and a single grass ofparticular type Truna Vishesha ; both altogether, can be used with a single term‘Grass’ similarly the term Madhumeha can be used for all types of Prameha- SarvaPramehe and for Madhumeha Visheshe - Vatika Prameha. Here for the present studyit is taken in terms of all types of Prameha not within the paradigm of its counterpart.Hence, Asadhyata of Madhumeha is justified42, 110.Discussion on Nidana: Literally and even clinically the extent of importance givento the role of Nidana in the causation of this condition is well established from bothAyurvedic and Modern parlance of etiopathogenesis and also the Nidana visheshataand its role in causing particular extent of Doshic vitiation along with itscorresponding path of vitiating particular Dhatu, mirrors the extent of underlyingPathophysiology and its clinical manifestation altogether. They highlight thesedentary lifestyle along with indiscrete usage of food stuffs as the main reason forthe disease. When it comes to the discrete usage of food items especially for thiscondition, lot of explanatory theories from Dravyaguna specialty will be supportivefor an Evidence Based Therapeutic and Disease Specific Dietary Approach42, 121. ‐ 140‐   
  • 151. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) Discussion on Purvarupa and Rupa: The Rupa and Purvarupa of Madhumeha areconsidered to be similar by Acharya Gangadhara. This is quite similar to the clinicalfeatures of Diabetes Mellitus. But while dealing with symptoms like Karapada Dahaand Karapada Suptata, which are considered as Purvarupa of Prameha in ayurveda21while Peripheral Vasculopathies and Peripheral Neuropathies which inconcordance with the above are considered as the late complications of DiabetesMellitus by the Conventional Medicine121. The explanatory theory for the above are as follows, Acharya Susrutha hasproposed his theory that all Prameha will attain the state of Madhumeha- Vataja, ifnot treated at proper time81. So at the last stage of Prameha, the Purvarupa ofMadhumeha will appear itself as symptoms like Karapada Daha, KarapadaSuptata which is quite in accordance with the late complications of Diabetes Mellitusbut based on Vikara Vighata Bhava Abhava Prativishesha it do not hold good whenthe Purvarupa of Sarva Prameha is taken into consideration and is highly liable forPhysicians Cognitive Discretion42. The explanations for the manifestation of theabove along with the other Purvarupa are as follows,  Karapadathala Daha is considered due to Ashayapakarsha Gati of Pita. Itmay be also due to loss of Ambu tatva which has Sheeta property and required forPreenanam, failing of which results in Daha. Another theory from Charakacharyaincludes its relationship with the Vata Dosha as explained in the context of Avarana.Involvement of Rakthavaha Srothodushti is established by this clinical featureKarapada Daha, based on Asrayaasrayi Bhava between Raktha and Pita90. The theory of persistent hyperglycemia as the primary mediator forEndothelial Dysfunction as a result of increased rate of formation of ROS in andaround the tissues is well established as the underlying cause for PeripheralVasculopathies121 but, the extent of this pathology depends on the discretion of the ‐ 141‐   
  • 152. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) predisposing etiological factors inducing or triggering the inflammatory processwithin the tissues, which is in accordance with the importance of Vikara VighataBhava Abhava Vishesha principle of Ayurvedic Pathology54. Karapada Suptata: The Possible Explanatory Theory is; due toAshayapakarshaka Gati of Kapha and its relationship with the Vata dosha asexplained in the context of Avarana by Charakacharya90. The theory of accumulationof AGEs and its effect on the temporory dysfunction of the Peripheral Sensory Nervesand also its long term effect is suggestive of neurotoxicity from the sustainedhyperglycemic condition is well established121. Eventhough; with all the abovementioned theories, it is in accordance with the extent and localization of the vitiateddoshas like Kapha and Pita in relationship with the Vata Dosha as explained in thecontext of Avarana by Charakacharya and its discretion based on the Vikara VighataBhava Abhava Vishesha decides the prognosis of this clinical feature which in turnneeds lot of explanatory theories in the near future for facing the present EvidenceBased Medicine Era54. Pipasa Adhikata establishes the Udakavaha Srothodushti and is one amongthe cardinal features of Madhumeha which is termed as Polydypsia in DiabetesMellitus. The Srotomula of the Udakavaha Srothas is stated as Kloma.Sharngadhara111 refers Kloma as “thila”. This probably can be referred to AdrenalGlands which are responsible for the fluid balance of the body. Any disturbance inthe homeostasis of these glands will results in multi systemic dysfunction and oneamong which is severe Cellular Dehydration, which may be the reason for PipasaAdhikata in Madhumeha. The theory of a very high glucose level causing severe intraand extra cellular dehydration is well established for the causation of excessive thirstin Diabetes Mellitus121. ‐ 142‐   
  • 153. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  Mutravaha Srotodushti in Madhumeha is marked by Prabhutamutrata. Theestablished pathophysiological theory behind this clinical feature is excessive fluidloss through urination along with glucose causing severe extracellular and to someextent in the intracellular dehydration resulting in both Polyuria and also Polydypsiain Diabetes Mellitus120. Prabhutamutrata is due to decreased renal threshold by theKidneys brought about by higher glucose concentration of the blood. This leads toincreased Glomerular Filtration Rate (GFR) by the kidneys, which is stated asPolyuria in Diabetes Mellitus. Another established theory on increased urination isdue to the consequence of osmotic diuresis secondary to the sustained hyperglycemiaduring which along with the loss of glucose free water and various electrolytes arealso lost125. 112 It is “Bahvabadha Medas” and “Bahudrava Sleshma” which are stated tobe important dushya and dosha of Madhumeha. The Srotomula for Medas is given asVapavahana113 which may be pointing towards pancreas? but another relativeexplanation is towards the Peritoneum / Omentum for Acharya Chakrapaniexplanation towards Vapavahana as “Udarasthasnigdhavartika”. The pancreaticpathology leads to impaired glucose conversion in to triglycerides which is resultingin the so called Bahvabadha Meda that is in concordance with the harmful LDLcholesterol. As far as the Ojus in Madhumeha is concerned it is always the Apara ojuswhich is Ardhanjali Pramana which gets disturbed along with the elan vital and thesame circulates all over the body according to the explanatory theory of AcharyaChakrapani in Arhte Dashamahamuliya Adhyaya48. This disturbance can be inferredto be initiated right from the time of Nidana Sevena beyond the threshold and thentakes its initiative in bringing about the Dhatusamya Kriya during which it has tomove along with the dosha, and come across Dhatus concerned in bringing about the ‐ 143‐   
  • 154. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) Purvarupa depending upon Vighata Bhava Abhava Vishesha which in later stagedecides the acquisition of Rupa phase of pathology. From the modern parlance, therole of T-cell mediated tissue damage in type-2 diabetes mellitus is well establishedand it is the T-cell mediated immunity which takes the pivotal role during theprogression of the disease pathology through various stages of inflammation and itscorresponding tissue injury which leads to osmotic changes within the tissues whenglucose concentration in the blood increases. Here possible explanation can be; alongwith the body fluid tissue, it is the inflammatory mediators especially Cytokines, theβ-cell agonist which starts circulating all over the body through various systemicbarriers- predominantly Cardiac and Renal125; which hypothetically can be consideredas Kleda, Lasika, Dhatugata mala and vitiated dosha circulating in the blood andgetting excreted out by imparting the Samalatva to the urine along with the Ojusfinally responsible for Avilata of Mutra. Excessive Kshudha Adhikata is another important symptom which signifiesthe Medovaha Srotodushti and thus the pathogenesis established for Sthoulya byCharakacharya should be considered. This in turn establishes the Avaranata of Kaphadosha and Medas in relation to the Samana Vata. From the modern parlance, Failureto use glucose for energy leads to increased utilization and decreased storage ofproteins as well as fat. Therefore, a person with severe untreated Diabetes Mellitussuffers rapid weight loss and asthenia (lack of energy) despite eating large amounts offood Polyphagia. Without treatment, these metabolic abnormalities can cause severewasting of the body tissues and death within a few weeks125. Another important characteristic feature of the disease is Swedapravruthi.The Abadhamedas along with the vitiated Kapha Dosha, its Vishyandatva, Gurutat,Bahutvat and Vyayama Asahatvat is responsible for excessive Swedapravruthi. ‐ 144‐   
  • 155. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  Dourbalya is another signicant clinical feature of Madhumeha which hasgained more focus especially from all streams of medicine in recent days and theexplanation is Asamatvat Dhatunam according to Charakacharya and establishedtheory from the modern parlance is; due to the increased insulin resistance in type-2Diabetes Mellitus, the tissues fail to even utilize the available glucose and theperipheral tissues especially muscle tissue etc suffer then, as a result, it draws energyfrom the available fat tissue and also the proteins and finally causes asthenia or lackof energy or Dourbalya125. Atinidra and Atithandra- these are the significant clinical features which aresuggestive of vitiated state of Dhatu which decides the Pranashrita ojo dushti. ANSdysfunction is a well established theory in uncontrolled hyperglycemic condition.Another theory established clinically is the subjectss level of consciousness variesdepending upon the degree of Hyperosmolality125.Discussions on Samprapti: The most important concept in the vicious cycle ofpathology of Madhumeha is the significance of the Prakruta Kapha as Ojas which getsdisturbed and altered from Badhata to Abadhata48, 90. The Dushyas included are Meda, Mamsa, Sharira Kleda, Shukra, Shonita,Vasa, Majja, Lasika, Rasa and Oja. The special characteristic features of theseDushyas are in Bahvabadha form which is highly liable for physician’s cognitivediscretion90. From the modern parlance the following pathophysiological theories inrelationship with the type -2 Diabetes Mellitus are well established121, 125. 1. Impaired Lipoprotein Metabolism. 2. Endothelial Dysfunction. 3. Pro thrombotic state. 4. Atherogenic factor. 5. Inflammation. ‐ 145‐   
  • 156. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) These pathological theories are invariably supportive for the condition termed asMetabolic Syndrome or Syndrome X which is now considered as the changing trendof Diabetes Mellitus into a cardiovascular disorder125.The above explanatory theories highlights the importance Rasa Dhatu and RaktaDhatu and the srotas concerned which are the core substratum for the progression ofthe disease pathology and its complications in its later stages.Discussion on Upadrava: The esteemed emeritus foresight of the Ayurvedic seersover the Upadrava of this condition Madhumeha enlisted approximately thousandyears ago36, identified and named as Diabetic Carbuncles are now well justified withvarious explanatory theories based on the Altered Platelet Function along with theCoagulating and Fibrinolytic factors, Endothelial Dysfunction and increasedOxidative Stress121, 125. Recent DCCT studies reveal that these altered functions withvaried degree can manifest both in the early as well as in the advanced stage of thiscondition but commonly noticed diabetic complications are CAD, diabeticnephropathy and diabetic retinopathy. The above mentioned DCCT study alsohighlights the importance of importance of Vikara Vighata Bhava AbhavaPrativishesha even at the stage and site of causation and clinical manifestation ofthese complications termed as Pidakas which later leads to a clinical condition termedas Putipuyamamsa - Diabetic Gangrene. Pipasa, Arochaka, Avipaka, Atisara andVrushanayoravadaranam are few systemic complications mentioned in Ayurveda36.Discussion on Sadhyasadhyatha: Diabetes is not a curable disease; the treatmentStrategy is to enable subjects to lead lives Similar to those of healthy persons, whilepreventing complications through appropriate Treatment and Personal Management.To achieve this objective, it is important to reduce Psychological, Physical, andLifestyle Burdens and Restrictions due to diabetes as much as possible. So,evaluation of Health-Related Quality Of Life (HRQL) is of more important for ‐ 146‐   
  • 157. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) evaluating the burden on subjects and in selecting treatment methods. Health RelatedQuality of Life measurement provides a comprehensive evaluation of the subjects’shealth status which would provide additional information to laboratory data and alsowith the subjective symptoms which in turn highlights the importance and globalimplementation of Dinacharya, Rtucharya and discrete utilization of classicalformulations with drug specifications and supportive evidence based explanatorytheories for the same thus meeting the required standards of care globally. Based onVikara Vighata Bhava Abhava Prativishesha48, 54, it is still under the sacred healing artof Avastha Vishesha Chikitsa Jnana of Vedic Medicine which can provide effectivestandards of Diabetic Care and Prognosis which in turn is highly liable for Physician’sCognitive Discretion90.Discussion on Arishtalakshana: Severe persistent hyperglycemic condition leads tocell destruction with restricted elimination of the toxins causing fruity odour125; whichattracts flies even after the bath of the subjects which in turn is a sure prognostic signof death mentioned for Prameha68, 69 . The fruity breath odor of acetone furthersuggests the diagnosis of Diabetic Ketoacidosis125. This extensive hyperglycemiccondition may produce diabetic coma and lead to death125. 1. Discussion on Materials and MethodsDiscussion on Selection of Polyherbal formulation: The selection of Polyherbalformulation was based on the following considerations, a) The formulation should contain more potent ingredients. b) The ingredients should have more disease specific action on Madhumeha and dosha specific action with Mehagna property. c) The ingredients of the formulation should be cost effective and it should be easily available with minimum controversies. ‐ 147‐   
  • 158. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) The formulation Vatsakadi Qwatha mentioned in Sharangadhara Samhita fulfilledthe above considerations and hence selected for present clinical study.Discussion on Posology: The dose of the Polyherbal formulation is fixed as 50ml individed dose twice daily 15 min before food with equal quantity of Luke Warm Waterkeeping in view that dose specification of Qwatha Kalpana is fixed to be as 2 Palaper day by Acharya Sharangadhara110.Discussion on Inclusive Criteria: 1. The subjects with Prabhutamutrata, Avilamutrata, along with other classical symptoms and signs with Pipasa Adhikata, Kshudha Adhikata, Karapada Daha, Karapada Suptata, Swedapravruthi and Dourbalya is included since these are the cardinal features of the disease48. 2. Age group between 25-60yrs of either sex is included for the study. MODY affects individuals <25 yrs and recent DCCT study reveals the occurrence of diabetes is now considered more in middle aged persons due to growing erratic change in lifestyles. This is the reason for fixing the age range as described above123. 3. The Fasting Blood Glucose Level ranging from 126mg/dL-180dL, Post Prandial Blood Sugar level ranging from 160mg/dl-250mg/dl is selected considering the limitations of the present study. This is based on the W.H.O approved diagnostic criteria for Diabetes Mellitus123.Discussion on Exclusion Criteria: 1. Age groups above 60 yrs and below 25yrs are avoided. In subjects above 60 years the response of the medicine will be considerably below the expected due to increased percentage of catabolic activity along with the possible disease chronicity125. Subjects below 25 yrs avoided on the basis of the recent DCCT study revealing MODY onset is <25 yrs. PPBS level more than 250mg/dl is avoided considering the chronicity of the disease and limitations of the present study123. ‐ 148‐   
  • 159. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  2. Subjects suffering with systemic ailments like Renal Disorder, Cardiac disorder etc. is excluded since they need critical care and continuous monitoring. Sahaja and Jathaja Madhumeha w.s.r to MODY and other genetically predisposed diabetic conditions are excluded considering the limitations of the present study123. 3. Subjects with diabetic gangrene, carbuncles and other diabetic complications are excluded considering the limitation of available clinical data and supportive explanatory theories on the Polyherbal formulation for its condition specific implementation.Discussion on Diagnostic Criteria: The diagnosis depends on the classicalsymptoms like Prabhutamutrata, Avilamutrata, Pipasa Adhikata, Kshudha Adhikataalong with other classical symptoms etc. and laboratory work up on Fasting BloodSugar level ≥126 mg/dl and Post Prandial Blood Sugar level ≥200 mg/dl based onthe W.H.O proposed diagnostic criteria for Diabetes Mellitus 2009123, 125. WHO approved diagnostic criteria strictly recommends thatGlycated/Glycosalated hemoglobin, HBA1C should not be used for diagnosticpurpose. Here in the present study HBA1C was carried out before the treatment andafter 90 follow up period for assessing the pre and post – therapeutic effect of thePolyherbal formulation -Vatsakadi Qwatha over the long term glycemic control of thesubjects. HBA1C as an objective parameter has gained maximum focus due topeaking incidence of undiagnosed and untreated diabetic subjects; but should bereconsidered based on its availability and cost, for the future studies125.Discussion on Assessment criteria: Assessment on symptoms of Prabhutamutrata(increased amount and frequency of micturition), Avilamutrata, Pipasa Adhikata,Kshudha Adhikata, Swedapravruthi, Karapada Daha, Karapada Suptata, Dourbalyaand laboratory investigations like Fasting Blood Sugar, Post Prandial Blood Sugar,fasting urine sugar and Post Prandial urine sugar has been done according to the self ‐ 149‐   
  • 160. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) assessment criteria based on their normal values with grading ranges from 0-3.Thishas been done for statistical analytical purpose.Discussion on drop outs: In the present study, 30 subjects were screened anddiagnosed for Madhumeha in the conducted medical camp, out of which 5 subjectswere excluded from the study based on exclusion criteria. Among the remaining 25subjects, 20 subjects satisfying the inclusion criteria was been taken for statisticalanalysis, 5 subjects among whom 3 subjects had discontinued the treatment due totransportation inconvenience and 2 subjects failed to attend the subsequent firstfollow up without any reason and were considered as drop outs of the study. Theissue on Palatability of the Polyherbal formulation was absolutely nil among 20subjects who were included for the present study. 3. Discussion on observations related to demographic data1. Age: Among the 20 subjects; majority of the subjects were distributed primarilybetween the age ranges of 41 - 45yrs and secondarily between the age range of 36 –40, 51 - 55 and 56 – 60 years which clearly highlights the WHO data of ageoccurrence of type -2 Diabetes Mellitus. The possible explanatory theory is due to indiscreet day-to-day physical and mental activity sufficient enough not to burn awaythe hypercaloric diet along with the accelerated rate of catabolic activity due to thedisease identity of the present era – Stress which significantly affects the process ofageing121.2. Sex: Majority of the subjects were Females (75%) in the present study.Hypothetically; due to their inevitable, indiscrete and unorganized day-to-dayphysical and mental activities along with erratic dietary habits including untimely andjunk food stuffs121 which is evident within the age criteria.3. Religion: Majority were Hindus. It is due to the Hindu dominated study site. ‐ 150‐   
  • 161. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) 4. Educational qualifications: Majority of the subjects was graduated which ishighly supportive for the awareness required for their progressive health plans and itspositive outcome for leading a better quality and standards of diabetic life.5. Marital status: About 85% of subjects were married. Post marital life withoutorganization in their day-to-day physical and mental activities along with erraticdietary lifestyle is quite suggestive of the disease entity of present era – Stress121, 125.6. Occupation: Majority of the subjects were Homemakers (55%) which highlightsthe indiscrete day-to-day physical and mental activities with erratic dietary lifestyle.7. Habitat: Majority belongs to rural habitat, which supports the DCCT results withlack of required amount of discrete physical and mental activity for optimumutilization of the available quality of food stuffs.8. Socioeconomic status: About 70% of the subjects belonged to Middle IncomeGroup, which is quite favorable with the disease identity of present era.9. Desapradhanatha: 80% of subjects belonged to Anupa Desa, which is furtherfavorable for the vitiation of Kapha Dosha especially in those with sedentarylifestyle48. 4. Discussion on data related to Subjects Clinical Findings1) Discussion on main presenting complaints of the subjects: Although; majorityof the subjects presented with Dourbalya (100%) along with Karapada Daha (95%) asthe common presenting complaint, it was Pruritis Vulvae which presented in almost10 female subjects along with Dourbalya and Karapada Daha which is quitesuggestive of typical clinical presentation found in type-2 female diabetic subjects125.2) Discussions on personal history of the subjects:a) Discussion on data related to dietary regimen: Untimely Vegetarian Diet (55%)dominated Untimely Mixed Diet (45%) which is quite supportive for the progressionof the underlying pathology. Hence as a part of drug specification; and also as a ‐ 151‐   
  • 162. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) dietary and lifestyle modification, subjects were reinforced for taking timely, fibrousrich, vegetarian diet with complete abstinence from untimely, non vegetarian, andspicy food stuffs121,122.b) Discussion on data related to supplementary diet: Subjects who had coffee andtea as major supplementary diet were more affected (50% and 40% respectively). Theestablished theory is that caffeine present in the coffee and tea are potent enough totrigger and accelerate the rate of inflammation and thus the tissue injury caused due topersistent hyperglycemic condition which is also supportive for reduced insulinsensitivity and increased insulin resistance. As a part of drug and disease specificationit was strictly advised for a regulated dose of these beverages while chats, soft drinkswere completely restrained from the subject’s dietary regimen.c) Discussion on data related to Vyasana: Five of the female subjects were reportedto have habit of pan chewing and 02 male subjects were reported to have the habit ofcigarette smoking which is known for amplifying inflammation via AGEs121, 122.d) Discussion on data related to Agni and Koshta: Vishamagni and Mandagni wereobserved in maximum number of subjects which clearly indicates the status of Kruraand Madhyama Koshta in relation with the dosha and its extent of vitiation in causingthe clinical manifestation of Purvarupa in Madhumeha subjects based on VikaraVighata Bhava Abhava Prativishesha48.e) Discussion on data related to Stress: 50% of the subjects revealed disturbed sleepwhich contributes for the HPA axis dysfunction. At the same time 85 % of thesubjects were observed to have Madhyama satva and 15% with Avara satva which isquite supportive for susceptibility to Peak Stress Crisis and the subsequent episodes ofpersistent hyperglycemic condition leading to Immune suppression121, 122. ‐ 152‐   
  • 163. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) 3) Discussion on data related to Systemic effect:a) BODY MASS INDEX: Majority of the subjects came under the paradigm ofnormal range while two were under over weight and another was within the obeserange. This in turn highlights the presence of possible Mild Hypertensive conditionand also Atherosclerotic Vascular Changes as established in updated version ofCMDT 2009125.b) EVIDENCE OF INSULIN RESISTANCE: The signs of dehydration like dryflaky skin and Acanthosis Nigricans are quite suggestive of Udakavaha andMamsavaha Srotodushti which in turn can be considered as the evidence ofunderlying insulin resistance and was observed only in few subjects.4) Discussion on data related to Prakruthi: In the present study; Vatakapha Prakruti(35%) showed maximum tendency of getting Madhumeha and subsequently byKaphapitha and Vatapita Prakruti for about 25% each. The disturbed state of AmbuTatva of Kapha, Agneya tatva of Pita and Yogavahi Tatva of Vata altogether or incombination with one another plays a vital amplifying role in the successiveprogression of vicious cycle of pathology at various levels with varied degree withinthe Dhatu in Madhumeha.5) Discussion on data related to Vikruthi: The observation on Vikruthi showedsignificant involvement of Rasa (100%), Medas (100%), Rakta (85%), Mamsa (90%),and Shukra (45%) Dhatu’s respectively. This clearly signifies the affliction ofrespective Avaraka Dosha- Kapha and Pita predominantly and Vata in correspondingDhatu in varied degree. Based on Ashrayaashrayi Bhava and Vikara Vighata BhavaAbhava Prativishesha; the Vikruthi in all the subjects’ falls within the paradigm ofMadhyama and Avara.6) Discussion on data related to Nidana: The observation on Nidana revealedimportant factors like untimely food habits – Carbohydrate, Fat rich diet, excessive ‐ 153‐   
  • 164. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) junk foods, spicy non vegetarian diet (100%), indiscrete aimless physical activities(100%) along with enough worthless worries, anger, grief and frustrations andemotional breakdowns (100%) responsible enough to initiate and amplify the viciouscycle of pathology of the disease Madhumeha, both from the ayurveda and modernparlance.7) Discussion on data related to Dhatu involved symptoms: Alasya;Procrastination, a Rasa Dhatu involved symptom is observed in 100% of the subjectsis suggestive of impaired Dhatvagni –process of tissue metabolism in Madhumeha.Swedapravruthi and Dourbalya are suggestive of Medo Dhatu involvement inMadhumeha. Karapada Daha and Karapada Suptata are suggestive of Rakta Dhatuand its Upadhatu involvement. 5. DISCUSSION ON DIABETIC QUALITY OF LIFE Although;  Quality of life is a subjective and complicated experience which iswidely used as an indicator in different recent clinical trials and descriptive studies oneither types of Diabetes Mellitus, here only Selective and relevant Questions from theWHO approved and DCCT validated Questions in relation with the clinical findingsrelated to type-2 were adopted for assessing and scoring of Diabetic Quality Of Life.Various recent DCCT studies on DQOL have revealed that there seems to have anegligible relationship between QOL and age or duration of diabetes but it is thephysical signs and symptoms which have shown a remarkable relationship with theQOL of the diabetic subjects. As per the recent objectives proposed by WHO on diabetics patient care; allthe subjects were sufficiently co-operative for assessing the diabetic quality of lifewhich revealed a remarkable compliance with higher QOL in Physical (100%),Sexual (90%), Treatment Satisfaction (50%) and in Health Perception which was ‐ 154‐   
  • 165. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) changed in 50% of the subjects from fair to excellent score even after the follow upperiod. The possible explanation for these findings is that firstly; majority of subjectswere new patients having diagnosed DM < 3 years with no complications and on noOral Hypoglycemic Agents Secondly, significant relief in the subjective parametersespecially of Dourbalya (P<0.001) even after follow up period. Although; goodcompliance was observed after the duration of treatment in Psychosocial (50%) andLife Satisfaction (40%) along with the above aspects of QOL, it showed faircompliance after the follow up period. 6. PROBABLE MODE OF ACTION OF VATSAKADI QWATHA Considering the findings based on the Vikara Vighata Bhava AbhavaPrativishesha; the probable mode of action of the Polyherbal formulation–VatsakadiQwatha can be analyzed based on the involvement of respective Dosha, Dushya,Sanga and Atipravruti type of Srotodushti and Agni, as the main pillars of discussion. The possible explanatory theories supporting the probable mode of action ofthe Polyherbal formulation- Vatsakadi Qwatha used for the present study arediscussed hereafter based on the following headings,1. Probable mode of action on assessment Criteria’s.2. Based on the theory of Rasa Panchaka.3. Based on Recent Drug Research.4. Based on Phytochemical analysis. 1. PROBABLE MODE OF ACTION OF VATSAKADI QWATHA ON SUBJECTIVE PARAMETERSa. Mode of action on Prabhutamutrata: The possible explanatory theory; KaphaPita Kleda Upashoshana Kriya of Vatsaka and Mala Shodhana effect of Triphala,Daruharidra, Musta and Bijaka might possibly have helped in regulating the ‐ 155‐   
  • 166. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) amount and frequency of micturition which on the other side might support the theoryof inhibiting inflammation induced excessive cellular dehydration caused due topersistent hyperglycemic condition120, 121, 122.b. Mode of action on Avilamutrata: The possible explanatory theory; Amapachana,Vatanulomana Kriya, Mala Shodhana, and Kaphapita Nashaka Kriya of Triphala,Dosha Pachana Kriya of Daruharidra, Rasayana Kriya of all the drugs mightpossibly have helped in rectifying the Samalatva of Mutra to Nirmalatva which on theother side might support the theory of glycemic control through restricting theformation of AGEs and its timely evacuation from the body121, 122.c. Mode of action on Pipasa Adhikata: The possible explanatory theory; TrushnaNigrahana Kriya of Musta and the Qwatha Kalpana might have possibly helped inregulating the above symptom which on the other side supports the theory ofregulating the fluid and electrolytic balance by inhibiting inflammation inducedexcessive cellular dehydration and subsequent fluid and electrolyte loss caused due topersistent hyperglycemic condition120, 121, 122.d. Mode of action on Kshudha Adhikata: The possible explanatory theory;Amapachana, Kaphapita dosha Shamana, Medohara Kriya of Musta, Bijaka,Daruharidra along with Vatanulomana Kriya of Triphala might possibly havehelped in removing the Avarana between Vata Dosha and Medo Dhatu therebyrectifying Kshudha Adhikata, which on the other side might support the theory ofregulating the Hepatic and Intestinal Metabolic Activity122. e. Mode of action on Karapada Daha: The possible explanatory theory is KledaUpashoshana Kriya of Vatsaka, Amapachana, Kaphapita dosha Shamana,Vatanulomana Kriya of Triphala along with Rasayana Kriya might have helped inbringing back the Dosha - Pitakapha to their normal site and perform normalphysiological function thereby rectifying Karapada Daha which on the other side ‐ 156‐   
  • 167. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) might support the theory of reducing the persistent hyperglycemic condition inducedTissue Injury and the subsequent Endothelial Dysfunction121,122.f. Mode of action on Karapada Suptata: The possible explanatory theory is KledaUpashoshana Kriya of Vatsaka, Amapachana, Kaphapita dosha Shamana,Vatanulomana Kriya of Triphala along with Rasayana Kriya might have helped inbringing back the Dosha – Kaphapita to their normal site and perform normalphysiological function thereby rectifying Karapada suptata which on the other sidemight support the theory of reducing the persistent hyperglycemic condition inducedROS formation and its subsequent Neurotoxicity121.g. Mode of action on Dourbalya: The possible explanatory theory ; Agni Deepana,Amapachana, Srotoshodhana, Malashodhana, Srotoshudhi, Malashudhi and RasayanaKriya of all the drugs in the Polyherbal formulation might possibly have helped inrectifying Dourbalya which on the other side might support the theory of multisystemic and synergistic anti-inflammatory and anti hyperglycemic action of all thedrugs in the Polyherbal formulation promoting enhanced insulin sensitivity andreduced insulin resistance, most importantly enhancing the hepatic uptake of glucoseand subsequent process of Glyconeogenesis followed by proper utilization of glucoseby the peripheral tissue121,122.h. Mode of action on Swedapravruthi: The possible explanatory theories are AgniDeepana, Amapachana, Kleda Upashoshana along with Srotoshodhana, Medoharaand Rasayana Kriya of all the drugs in the Polyherbal formulation might possiblyhave helped in reducing the Adhika Sweda Pravruthi which on the other side mightpossibly support the theory of reduced Lipid Peroxidation especially within theliver122. ‐ 157‐   
  • 168. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)   OBJECTIVE PARAMETERS:a. EFFECT ON FASTING BLOOD SUGAR LEVEL: It signifies the enhanced process of hepatic gluconeogenesis which is hampered due to persistent hyperglycemic level.b. EFFECT ON POST PRANDIAL BLOOD SUGAR LEVEL: It signifies the process of glucose uptake by the peripheral tissues especially skeletal muscles induced by reduced insulin resistance.c. EFFECT ON FASTING URINE SUGAR: It signifies the reduction in the renal threshold..d. EFFECT ON POST PRANDIAL URINE SUGAR: It also signifies the glycemic control especially enhanced insulin sensitivity and reduced insulin resistance in the peripheral tissues.e. EFFECT ON HBA1C: Although not much change was observed after the follow up period it still signifies the accummulation of AGEs along with a long term glucose control. 2. BASED ON THEORY OF RASA PANCHAKA a) Probable mode of action based on the Rasa: If we analyze the percentage of Rasa –Inspite of the presence of Lavanavarjita Pacharasa Yukta Oshadhi Dravya like Amalaki and Haritaki the formulation is dominated by Kashaya. Tikta and Katu Rasa’s because of the presence of Vatsaka, Daruharidra, Musta and Bijaka. From the above criteria, it is evident that Kaphapita Nashaka Kriya and Vata Shamana Kriya are possible from this Polyherbal formulation. So; Vatsakadi Qwatha is potent enough to bring back Prakupita Kaphapita Dosha, which is responsible for Margavarana of the vata dosha to its balanced state and thus breaking the vicious cycle of pathogenesis of the disease Madhumeha. At the same time, it nullifies the effect of the toxic exposure of the Dhatu’s to the same and promotes restoration. ‐ 158‐   
  • 169. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) b) Probable mode of action based on Guna: It is nothing short of a miracle that allthe drugs in the Polyherbal formulation- Vatsakadi Qwatha are possessing Laghu andRuksha Guna in common but liable for discretion regarding its extent. However; thecriteria is quite supportive for the required Ulekhana action for Srotoshudhi, which inturn provides Medohara, Kaphahara and Lina dosha Nashaka effect altogether.c) Probable mode of action based on Virya: The drugs in the Polyherbalformulation- Vatsakadi Qwatha possess Ushna and Sheeta Virya in the ratio 4:3,which is quite supportive for not only for the reduction of Kleda an Lasika but also formaintaining the normal homeostatic nature of vata dosha by amplifying Tridoshaharaand Medohara effect and thus break up the vicious cycle of pathology of the diseaseMadhumeha. At the same time, it promotes the formation of Prashasta Dosha, Dhatuand thus restores Dhatu Samyatva.d) Probable mode of action based on Vipaka: The drugs in the Polyherbalformulation- Vatsakadi Qwatha possess Madhura and Katu Vipaka in the ratio 3:3,which is quite supportive for promoting and restoring the normal functions of thedamaged Dhatu by nullifying and rejuvenating the Dhatu from the effect of PrakupitaDosha and thus restore Dhatu Samyatva.e) Probable mode of action based on Karma: The drugs in the Polyherbalformulation- Vatsakadi Qwatha possess Kaphapitahara and Tridoshahara activity inthe ratio 5:2 and also with Kledopashoshana, Sangrahi, Jvaragna, Medohara, Mutrala,Chakshushya, Trushnanigrahana, Kandugna, Kushtagna, Stanya Shodaka,Virechnopaga, Rasayana and Vajeekarana activities altogether responsible forrestoration of Dhatu Samyatva. ‐ 159‐   
  • 170. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  3. BASED ON RECENT DRUG RESEARCH124As already mentioned in the introductory section of this study; there are few drugs inthe Polyherbal formulation- Vatsakadi Qwatha, which are proven to havehypoglycemic effect and are also on the verge of proving various other biologicaleffect over the human body. They are,1. Vatsaka: Anti-Oxidant, Anti-Bacterial, Anti-Inflammatory, Anti-Viral and AntiDiarrheal – these actions might possibly have helped in overcoming the process ofpathological cycle within the intestines by reducing the inflammatory tissue responseand regulating the absorptive nature of the intestinal bacterial flora by strengtheningand toning up the intestinal walls by timely evacuation of AGEs from the system122,which correlates with the theory of Charakacharya - Kapharaktapitasangrahana TathaUpashoshananam Kutaja Tvak – liable for physician’s cognitive discretion104. Thisalso supports for the pacification of Pruritis vulvae and generalized body itching –Hepatoprotective action on the verge to be established122, 124.2. Triphala: Anti-Oxidant, Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory,Hepatoprotective, Cardioprotective and Anti-Diabetic activity of Haritaki, Amalakiand Vibhitaki with carbohydrate rich content are potent enough to reduce the viciouscycle of pathology by timely evacuation of AGEs from the blood stream and β-cellstimulation. In coordination with the other drugs it reduces the insulin resistance andincreases the insulin sensitivity of the peripheral tissues by stimulating Adiponectin, apotent Insulin Sensitizer122, 124 . The above description can be justified with thefollowing reference ||Triphala Kapha Pitagni Mehakushtahara Apara | ChakshushyaDipani Vrushya Vishama Jvara Nashini ||1043. Daruharidra - Anti-Oxidant, Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory,Hepatic Stimulant, Hepatoprotective, Anti-Ulcerogenic, Anti-Adhesive Anti-Bacterial, Anti-Platelet Aggregation and Anti-Diabetic activity; mimics Anti-Septic ‐ 160‐   
  • 171. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) and Anti Pruritic on the verge for its establishment altogether promotes glycemiccontrol right from correcting the Cardiohepatic – due to Anti-Arrhythmic effect andprotects hepatocellular damage due to persistent hyperglycemic state, Cardiorenalsystemic dysfunction synergistically122, 124..4. Musta- Anti-Pyretic, Anti-Lipidemic, Anti Inflammatory, Hepatic Stimulant,Hepatoprotective, diuretic activities which are already established – are supportiveenough to bring about the glycemic control by correcting the cellular dehydration andosmotic diuresis121,122, 124.5. Bijaka- Anti-Hyperglycemic, Anti- Hyperlipidemic, Cardiotonic,Hepatoprotective, Anti Oxidant, Anti Inflammatory, insulin- like activities are quitesupportive for glycemic control and reduction in common symptoms of DiabetesMellitus through correcting the pathway of insulin by protecting and restoring the β-cell function, reducing the inflammatory tissue response by inhibiting theprostaglandin and COX-2 inhibiting activity, also protecting the hepatocellulardamage122, 124. Also recent study entitled “Effect of Triphala in pancreatitis for β cellrestoration” is really encouraging for the life science professionals for having anupper hand for the better standards of diabetic care in the near future. ‐ 161‐   
  • 172. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM)  4. BASED ON PHYTOCHEMICAL ANALYSISThe Phytochemical and qualitative study result and its relevance are as follows, 1. The Acidic pH value in this Polyherbal formulation Vatsakadi Qwatha– amplifies the rate of absorption of the drug within the Stomach, Upper gastrointestinal tract thus rendering better bioavailability in the intestines. 2. The Specific Gravity of Vatakadi Qwatha- 1037 – which might possibly have supported in better absorption of the drug.Carbohydrates –present in this Polyherbal formulation Vatsakadi Qwatha.Plantenergy storage components are referred to as carbohydrates. Plant starch, gums,mucilage, cellulose are all Polysaccharides. These along with their derivatives areknown to exert a beneficial action on the bodys immune system, increasing instrength, whose derivatives have been developed as bulking agents for the alleviationof constipation and as agents meant to reduce the appetite (Ref - Tyler et.al.44-45).Bitter Tannins - These bitter tannins along with the Anthroquinone glycosides inVatsaka, Triphala etc. are known for their Anti-hyperglycemic, Anti-inflammatory,Anti-diarrheal, Anti-viral, Antiparasitic, Anti-allergic, Anti-thrombotic andVasoprotective properties. These plant constituents exert antioxidant effects on freeradicals in the body – (Ref - Plant Material Medica and Harborne and Baxter, 84).Alkaloids - Alkaloids like Conessine in Vatsaka for Anti Inflammatory, Anti Oxidantand Vaso protective action – Chemistry of Natural Compounds. Vol.35, 1999,Berberine in Daruharidra, Epicatechin in Bijaka etc is known for their Anti-hyperglycemic, anti-lipidemic, Hepatoprotective action –(Ref- Dukes PhytochemicalAnd Ethnobotanical Database).Saponins – Sesquiterpenoids, Terpenoid Saponins in Musta for Anti Inflammatory,Anti Pyretic, Hepatoprotective and Anti lipidemic action and also for have been used ‐ 162‐   
  • 173. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) to stimulate actions within the body such as mucosal or gastric secretion,  as anantibiotic, antiviral, and bitter tonic – DeFeudis, 1991; Harborne and Baxter,PD2447; Petkov et al., 106).Steroidal Saponins – Pterostilbene in Bijaka is proven to be Cardiotonic andHepatoprotective - Harborne and Baxter, 689.Phytosterols – These are necessary plant membranes and plant cell growths. B-Sitosterol decreases the risk of atherosclerosis by lowering plasma concentrations ofLDLs (low-density lipoproteins) - Lehninger, 614.Phenolic and Flavanoid compounds - These are known to be beneficial as powerfulAntioxidants, Stress Modifiers, Anti-Allergic agents, Anti-Viral compounds and Anti-Carcinogens - Evans, 420. Some are able to stimulate protein synthesis, and some areknown Anti Inflammatory agents. Still others have demonstrated Vaso-protectiveactivity. Some are Diuretic, Antispasmodic, Antibacterial, and Antifungal - Harborneand Baxter, 367-415.All the above Chemical Compounds and proposed pharmacokinetic activity present inVatsakadi Qwatha supports and fulfills the recent pharmacological invention relatedto a herbal composition for the treatment of Diabetic Mellitus and MetabolicSyndrome where in one of its embodiment; the invention provides a compositioncomprising of anti hypoglycemic agent, anti inflammatory agent, anti hyperlipidemicagent, anti oxidant agent and a gastro intestinal agent with at least one of these agentsbeing derived from a plant while, Vatsakadi Qwatha completely satisfies with allfrom the plant source itself. All the above theories related to the drug review fulfills the purpose ofbringing about synergistic action by the Polyherbal Formulation-Vatsakadi Qwathaand thus potent enough to break the vicious cycle of pathogenesis – Samprapti ‐ 163‐   
  • 174. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r. to Diabetes Mellitus (NIDDM) Vighatana in Global Systemic Illness like Madhumeha vis a vis type-2 DiabetesMellitus. MERITS AND DEMERITS OF THE POLYHERBAL FORMULATION VATSAKADI QWATHAThe following are the merits and demerits of the Polyherbal formulation – VatsakadiQwatha selected for the present study.MERITS: 1. A potent Polyherbal formulation for the management of Madhumeha w.s.r to diabetes mellitus (NIDDM). 2. All the drugs are easily available. 3. Palatability was satisfactory. 4. It has proved better effect in controlling glucose level in diabetics without any adverse events in the present study.DEMERITS: 1. It is costlier comparatively. 2. Portability was another demerit noticed in the present study. 3. Long term administration of the drug is still questionable due to Lack of sufficient clinical data. 4. Long term storage of this Qwatha is a problem. ‐ 164‐   
  • 175. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)   CONCLUSION After critical analysis and systematic clinical work, the following conclusions can be drawn on the action of formulation Vatsakadi Qwatha on Madhumeha.1. The disease review reveals lot of similarities between Madhumeha and Diabetes Mellitus and importance of Purvarupa of the disease extending into its Rupa phase is well established based on the emeritus concept of Vikara Vighata Bhava Abhava Prativishesha.2. Observation reveals those individuals who are accustomed to indiscrete physical and mental activities along with erratic dietary regimen especially in middle aged house wives showed maximum susceptibility for the disease Madhumeha.3. The clinical trial of Vatsakadi Qwatha showed significant reduction in all the clinical features, in particularly Dourbalya, Karapada Daha and Pipasa Adhikata reduced predominantly followed Prabhuthamutratha, Kshuda Adhikata, Swedapravruthi, Avilamutrata after 45 days of treatment period. After 90 days follow up period showed less significant in all the subjective parameters, except in Dourbalya.4. The clinical trial and assessment reveals the formulation successfully reduced FBS, PPBS, and Urine sugar levels within a short period of the treatment which signifies role of glycemic control by the Polyherbal formulation – Vatsakadi Qwatha.5. Observation on Glycated hemoglobin – HBA1C was not changed markedly with respect to pre and post test design.6. Overall effect reveals that, the formulation is highly significant during treatment period of 45 days. So it justifies the alternate hypothesis during the treatment period.7. The formulation showed insignificant result during the follow up period i.e 90 days of observation without medication. So it substantiates the null hypothesis after the follow up period. ‐ 164‐   
  • 176. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  8. The formulation did not show any adverse events either during the treatment period or during the follow up period. So this is suggestive that the drug Vatsakadi qwatha is an effective as well as an ideal drug for effective management of the disease Madhumeha w.s.r to Diabetes Mellitus (NIDDM). SCOPE OF FURTHER STUDY:1. As the study was conducted over a small sample, a similar study performed over a large sample for a longer period would have procured much sharper and accurate results.2. Comparative studies may provide the required specification for the formulation.3. Efficacy of the drug should be checked in type-1 and also in diabetic complications.4. The effect of the drug along with Shodhana therapy should be critically analysed.5. The efficacy of formulation in Ghana Vati Kalpana should be checked.6. To appreciate any positive changes with respect to the HBA1C, it would be ideal to administer the drug for more than 4 months. ‐ 165‐   
  • 177. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) SUMMARY The present study entitled “CLINICAL EVALUATION OF VATSAKADIQWATHA IN THE MANAGEMENT OF MADHUMEHA WITH SPECIALREFERENCE TO DIABETES MELLITUS (NIDDM)” comprises of differenttopics discussed under the following headings.1. Introduction: This section deals about Multi-Dimensional Ayurvedic Perceptiontowards the health, disease and therapeutics; brief analysis of the historicalbackground of the disease Madhumeha, its present status in 21stcentury withprevalence and incidence of the disease Madhumeha among world population.2. Objectives: This section deals with the main aims and objectives of the presentstudy along with the Null and Alternate Hypothesis.3. Review of Literature: This section deal with the collection of data regardingEtymology, Definition, Classification, Nidana, Purvarupa, Rupa, Samprapti,Sadhyasadhyata, Upadravas, Arishta Lakshanas and Chikitsa along with Pathyapathyaof the disease Madhumeha. This section also deals with the modern conceptiontowards the disease Diabetes Mellitus: its Clinical information, Diagnostic Criteriaapproved by WHO and its related therapeutic information.4. Methodology: This section deals with the detailed description of clinical studywith respect to Subject Grouping, Selection, Inclusion and Exclusion Criteria,Treatment Protocol, Duration of the Treatment, Assessment Criteria for bothSubjective and Objective Parameters along with Diabetic Quality of lifequestionnaire, Overall Assessment Criteria and Study Design of the present study. -166- 
  • 178. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)5. Results: This section deals with the result obtained after completion of 45 days ofTreatment and 90 days of Follow Up period. The scoring of Subjective and ObjectiveParameters of Madhumeha before and after treatment are statistically tabulated andpercentage of response is calculated and analyzed using student paired‘t’ test. Thetotal relief obtained after the treatment schedule was recorded as- i) GOOD RESPONSE. ii) MODERATE RESPONSE. iii) MILD RESPONSE. iv) POOR RESPONSE. After 45 days of Treatment Period, the investigational product VatsakadiQwatha showed good response in 10 subjects i.e 50%, Moderate response in 04subjects i.e 20%, Mild response in 04 subjects i.e 20% and Poor response in 02subjects i.e 10%. After 90 days of Follow Up period, the investigational product VatsakadiQwatha showed Good Response in only 02 subject’s i.e 10%, Moderate Response in04 subjects i.e 20%, Mild Response in 08 subjects i.e 40% and Poor Response in 06subjects i.e 30% Thus, the investigational product Vatsakadi Qwatha showed overallsignificant result during treatment period than compared to Follow Up Period.6. Discussion: This section deals with discussions pertaining to Nidana Panchaka,Observations and Results obtained from the present study. The probable mode ofaction of the investigational product Vatsakadi Qwatha based on Rasa Panchakatheory of individual drugs in relation with the management of Madhumeha has beendiscussed. This section also deals with the discussions regarding recent Pre-Clinical -167- 
  • 179. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)and Clinical Evidential Studies for each and every ingredients of the investigationalproduct Vatsakadi Qwatha along with its Phyto-Chemical Analysis.7. Conclusion: This section deals with the conclusion of the above study byhighlighting the outcome of the study and the scope for further studies. -168- 
  • 180. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) BIBLIOGRAPHY1. Acharya Agnivesha; Charaka Samhita; redacted by Charaka and Dridabala with Ayurveda Dipika Commentary by Chakrapani Dutta; edited by Vaidya Yadavji Trikamji Acharya; 4th Edition, 2001; published by Chaukhambha Surabharathi Prakashana Varanasi, Uttar Pradesh.2. Anonymous; Yogaratnakara, with Vidyotini Hindi Commentary by Vaidya Lakshmipathi Shastri; 7th Edition, 1999; Chaukhambha Sanskrit Samsthan, Varanasi, Uttar Pradesh.3. Baghel M. S.; Researches in Ayurveda; Ed. Gajendra Kumar Jain; First Edition, 1997; Mridu Ayurvedic Publication and Sales, Jamnagar, Gujarat.4. Acharya Bhavamishra; Bhavaprakasha, with Vidyothini Hindi Commentary by Bhishagratna Sri Bramha Shankara Shastri and Sri Roopalal Vaishya; Eighth Edition, 1997; Chaukhambha Sanskrit Bhavan, Varanasi, Uttar Pradesh.5. Davidson, Sir Stanley; Davidson’s principles and practice of medicine, Ed C. R. W. Edwards et al; 17th International Student edition 1995, reprinted 1998, Churchill Livingstone, Edinburgh.6. Harrison T. R. et al; Ed. Harrison’s principles of Internal Medicine; Vol. I & II, 17th International Edition, 1998; published by McGraw-Hill Book Co. Singapore.7. Acharya Madhavakara; Madhava Nidanam, Uttarardha with Madhukosha Vyakhya by Vijayarakshita and Srikanta Dutta, Vidyotini commentary by Ayurvedacharya Sri Sudarshana Shastri; 29th Edition, 1999; Chaukhambha Sanskrit Samsthan, Varanasi, Uttar Pradesh.8. Acharya Sushruta; Sushruta Samhita with Nibandha Sangraha Commentary of Sri Dalhana Acharya and Nyaya Chandrika Panjika of Sri Gayadasacharya; ed. by Vaidya Yadavji Trikamji Acharya and Narayana Ram Acharya; Reprinted Edition, 1998; Krishnadas Academy, Varanasi. Uttar Pradesh.9. Vagbhatacharya; Ashtanga Hrudaya with commentaries Sarvangasundara of Arunadutta and Ayurveda Rasayana of Hemadri, ed. by Pandith Bhishak Acharya, Hari Shastri Paradkar Akola; 8th Edition, 2000; Chaukhambha Orientalia, Varanasi, Uttar Pradesh.10. Kumar, Kotran, Robins; Robbins Basic Pathology 7thedition 2003 Elsevier India Pvt. Ltd, New Delhi.  
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  • 182. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)25. Dr Eric. J. Topol, Textbook of Cardiovascular Medicine®, Lippincott Williams and Wilkins, 3rd Edition.26. Dr James Dukes, Dukes Handbook Of Medicinal Herbs®, an e-book.27. Dr R.C.Guyton, M.D†, Dr John.E.Hall, M.D†, Textbook of Medical Physiology, 11th edition, Elsevier Saunders.28. Dr .Mark. N. Feingelos, M.D† and Dr M. Angelyn Bethel, M.D†, Contemporary Endocrinology™, Type -2 Diabetes Mellitus, an Evidence Based Approach to Practical Management, Humana Press.29. Stephen J. McPhee, Maxine A. Papadakis, Eds, Ralph Gonzales, Roni Zeiger, Online Eds. Current Medical Diagnosis and Treatment 2009, 48th edition, Tata McGraw Hill.Inc.30. Dr Bertram.G. Katzung, M.D†, PhD, Basic and Clinical Pharmacology, 10th edition, Tata McGraw Hill press, P.O. Box 0450, University of California, San Francisco, CA 94143-0450.  
  • 183. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) REFERENCES 1. D.P. P. M. Pg: 808 2 Ka. Su 26/6-10 3 Ha. S. IIIrd sthana 4 Ka. Su.25/22 5 Sha.Sam7 /59-62 6. Bha. Pra.Ma.Kha.38 7 Y. R - U. Pg. 82 8. D.M.I. Pg.14 9. Shabdakalpadruma 10 Vachaspathyam 11 R.V- S.B (10/163/5) 12 A.H.Ni.10/18, Cha.Ni.4/44 13 Cha.Su.17/80 14 The Diabetes – Parashuram Shastry 15 Su.Chi.11/3 16 Cha.Chi.6/4 17 Su.Ni.6/3 18 A.H .Ni. 10/1-3 19 Cha.Ni.4/5 20 Cha.Ni.4/24 21 Cha.Ni.4/36 22 Cha.Su.17/78 23 Su.Ni.6/30 24 D.P. P.M.-Pg: 811,812 25 Cha. Ni 4/47 26 Su. Ni 6/5 27 A. H. Ni 10/38, 39 28 A.S .Ni 10/7 29 Ma.Ni 33/5 30 Su.Ni.6/25-26 31 Cha.Ni.4/44 32 A.P.I.T.M.-. Pg.1050  
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  • 186. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM) 102 Journal of Research in Ayurveda and Sidha v.21 (1-2):p.11-18, 2000 (Eng; 15ref). [Effect of Bala Haritaki on Hyper Cholesterolaemia- Sood.R; Sharma A. K (P.G Dept. of KC, Jaipur] 103 DRAVYA GUNA Vol II- J. L. N. Shastry Pg. 216 104 Yadavji Trikamji Acharya, Dravya guna, vol-3. 105 BMC Complimentary and Alternative Medicine 2006 106 DRAVYA GUNA Vol II- J.L.N. Shastry Pg. 314 107 Pillai et al (DRAVYA GUNA Vol II- J.L.N. Shastry page 315 ) 108 DRAVYA GUNA Vol II- J. L. N. Shastry, Pg.152 109 Biological and Pharmaceutical Bulletin-The pharmaceutical Corporation of Japan 2004 - JA, www.3pdf.com. 110 Chakradutta.D.Prameha Chikitsa-35/19. 111 Sha. Sam.P.K-4/45 112 Cha. Ni 4/6 113 Cha. Vi 5/8 114 The Lancet, Volume 360,Issue 9344,page 1477- 478(R.VanDam, E.Feskens) Elsivier.com 115 Journal- Diabetologia [( Issue-Vol- 49, page 1770-1776 )] dated 08/Aug2006)] 116 Fitoterapia, issue1, January 2004 pages 1-4, Anti-diabetic potential of Pterocarpus marsupium extracts in rats. 117 Effects of red wine, tannic acid, or ethanol on glucose tolerance in non Insulin Dependent Diabetic Patients and on starch digestibility in vitro Universite de Ordeaux II, Bordeaux Cedex, France) Journal of Ethnopharmacology, vol108, issue2, Nov 2006 page 280-286. 118 Indian Journal of pharmacology, 2010, Source – www.ijp-online.com. 119 Net source - http://www.bionewsonline.com/i/2/antimicrobial_b.html. 120 Textbook of Medical Physiology, Guyton 11th edition chapter 78. 121 Textbook of Cardiovascular Medicine Eric j Topol 3rd edition. 122 Type 2 Diabetes Mellitus by mark n Feinglos and M Angelen Bethel. 123 Handbook of diabetes mellitus by Dr V. Seshiah, Chennai. 124 Dukes handbook of medicinal herbs 125 Ayurvedic Pharmacopoeia of India. 126 Current Medical Diagnosis and Treatment- 2009.  
  • 187. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  CASE REPORT FORM POST GRADUATE DEPARTMENT OF KAYACHIKITSA A.L.N. RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE, KOPPA P.G. Scholar: Dr.Srikrishna H.A Guide: Dr .Suresh. R.D, MD (Ayu), MS(C&P),CYS.. Patient’s Name: SL No: Age/ Sex: ….Yrs M/F OPD/IPD: Religion: Ward/Bed No: Education: D.O.A: Marital Status: D.O.D: Occupation: Diagnosis: Postal Address: Result: PATIENT CONSENT FORM I __________________________________________ exercising my free power of choice, hereby give you my complete consent to be included as a subject in the present Clinical Study. I have been informed to my satisfaction by the attending Doctor, the purpose of the Clinical Study and the nature of drug treatment, therapeutic procedures, follow-up and probable complications. I am also ready to undergo necessary Laboratory Investigations to monitor and safeguard my body functions. I am also aware of my right to opt out of the trial at any time during the course of the trial without having to give the reasons for doing so. Signature of the Doctor Signature of the Patient/ Guardian  
  • 188. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  CHIEF COMPLAINTS 1) Prabhutamutrata with Duration: Amount of urine: Markedly increased / Increased / slightly increased/Normal Frequency of urination: Diurnal: Markedly increased / Increased/ Slightly increased/ Normal Nocturnal: Markedly increased/ Increased/ Slightly increased/ Normal 2) Avilamootrata (Turbid Urine) with Duration: Appearance of Urine: Grading with Standard Sample (Testube Background News paper method) Clearly readable/Readable/can read with difficulty/cannot read the letters. 3) Pipasa with Duration: Markedly increased / Increased / slightly increased/Normal 4) Kshudha with Duration: Markedly increased / Increased/ slightly increased/ Normal 5) Sweda Pravruthi with Duration: Markedly increased / Increased/ slightly increased/ Normal 6) Karapadathala Daha with Duration: Markedly increased / Increased / slightly increased/Normal 7) Karapadathala Suptata with Duration: Markedly increased / Increased / slightly increased/Normal 8) Dourbalyam with Duration: Markedly increased / Increased / slightly increased/Normal HISTORY OF PRESENT ILLNESS HISTORY OF PAST ILLNESS FAMILY HISTORY  
  • 189. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  1. Known DM in first degree relative - Present/Absent 2. Known DM in second degree relative - Present/Absent 3. Known DM in third degree relative - Present/Absent PERSONAL HISTORY Habits: Micturition: Diet: Bowel habit: Vyayama: Appetite: Nidra: Others: MENSTRUAL HISTORY GENERAL EXAMINATION Pulse: Built: B.P: Pallor: Temperature: Icterus: Heart Rate: Cyanosis: Respiratory rate: Edema: Lymphadenopathy: Nail changes: Height: Weight: Physique: Obese / Moderately Built/ Asthenic SYSTEMIC EXAMINATION 1. Urinary System: Inspection: Skin: Dry and flaky / dirty brown appearance / Uremic frost on the forehead / Pitting oedema on ankles and sacrum/oedema at genitals/facial puffiness. Nail: Leuconychia/Splinter Hemorrhages Palpation: Left kidney: Palpable lower end (abnormal) /not palpable (normal) Right kidney: Lower end Palpable (normal) / not palpable (if removed) If abnormal: Unilaterally palpable kidney / bilaterally palpable kidney 2. Cardiovascular System: Inspection and palpation:  
  • 190. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  Arterial pulse: Tachycardia/Bradycardia/normal Rhythm: Normal/abnormal Abnormal pulsations on Precordium: present/absent Blood Pressure: Auscultation: Abnormal Heart Sounds: Murmurs/ Additional heart sounds The peripheral pulses of upper limb: All present and equal/ All present and unequal/Absence of pulses noted. The peripheral pulses of lower limb: All present and equal/ all present and unequal/Absence of pulses noted. Bruits: Present/Absent Abnormalities on ECG: Central Nervous System: Mental stage: Gait: Cranial Nerves: Fundi: Pappiloedema: Present/Absent Optic atrophy: Normal/Abnormal Hypertensive changes/Ureamic changes/Diabetic changes Motor: Sensory: Position sense in fingers and toes (Post. Columns): Normal/ Abnormal Pin prick test of limbs and face (Lateral Spinothalamic tract): Normal/Abnormal Response to light touch - positive/negative. ASTASTANA PAREEKSHA: 1. Nadi: 5. Sabda: 2. Muthram: 6. Sparsa: 3. Malam: 7. Drik:  
  • 191. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  4. Jihwa: 8. Akruti: DASAVIDHA PAREEKSHA Prakruthi: Sara: Samhanana: Pramana: Satva: Satmya: Vyayamasakthi: Aharasakthi: Vaya: Vikruthi: SROTHO PAREEKSHA 1. Udakavahasrothas: Jihva Shosha/ Talu Shosha/Oshta Shosha/Kanta Shosha/Mukha Shosha/Tamas/ Pravrudhapipasa 2. Rasavahasrotas: Shithilagatrata/ Karapadasupthatha/ Klaibya/ Shrama/Agnimandya/Gourava/Alasya/Atinidra/Asyamadhurya/Arasajn ata/Aruchi 3. Rakthavahasrotas: Karapadasupthatha/ Karapadadaha/ Rakthasrava/ Pidaka/ Vidradhi/ Kotha/ Mukhapaaka 4. Muthravahasrothas: Prabhuthamutrata/ Avilamutrata/ Makshikaakranta Mutrata (Pipilika Abhisarana)/ Sashulamutrata NIDANAM 1. AHARAM Present Absent a) Excess carbohydrate rich Diet (Rice, Jaggery and Grains etc..) b) Excess fat rich Diet (Curd, Anupa mamsa, Oudaka Mamsa, Butter, Sweets, Mamsa of Domestic animals) c) Amount of food Mild Moderate Excess 2. VIHARAM Present Absent  
  • 192. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  a) Asyasukham (Sedentary sitting & Sex habits) b) Swapnasukham (Sedentary sleeping Habits) c) Lack of exercise 3. MANASIKA NIDANA Present Absent a) Chintha b) Shoka c) Udwega PURVARUPAM Present Absent a) Karapadathaladaham b) Pipasa c) Dantamalam d) Nayanamalam e) Karnamalam f) Alasyam g) Shareera Dourgandhyam h) Athinidra i) Athithandra j) Karapadathalasuptatha k) Keseshu Jatileebhavam l) Asyamadhuryam DHATU INVOLVED SYMPTOMS a) Rasa (Vruddhi): Praseka/ Alasya/ Gaurava b) Medas (Vrudhi): Shramaswasa,/ Lambhana of Sphik/Stana c) Majja (Ksheena): Asthisousheerya - Present/ Absent d) Vasa (Ksheena): Mamsakshaya - Present/ Absent  
  • 193. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  e) Lasika: Mamsatwagantara Udaka Kshaya - Present/Absent f) Ojus (Ksheena): Impaired Psychological, physical or Disease Specific strength of the individual - Present/ Absent UPASAYAM / ANUPASAYAM SAMPRAPTI GHATAKA Dosha : Dushya : Srotas : Srotodushti : Agni : Ama : Udbhava sthana : Sanchara Sthana: Adhishtana : Vyaktha sthana: Rogamarga : Vyadhi swarupa : INVESTIGATIONS BIOCHEMICAL RESULTSNo INVESTIGATIONS 1 F.B.S 2 P.P.B.S 3 HbA1C 4 F.U.S5. P.P.U.S DIAGNOSIS: Madhumeha Treatment Started on: Treatment Ended on: Follow up Started on: Follow up Ended on: Medicine: Vatsakadi Qwatha Treatment Duration: 45 days Follow up Duration: 90 days.  
  • 194. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)   ASSESMENT OF RESULTSNo Parameters B.T D.T AT AFU Subjective 0 15 30 45 60 75 90 105 120 1351.a P.M(Amount) B P.M (Frequency)2 Avilamutrata3 Pipasa4 Kshudha5 Sweda Pravruthi6 Karapadathala Daha7 Karapadathala Suptata8 Dourbalyam Objective 0 15 30 45 60 75 90 105 120 1351 Blood Sugar FBS PPBS HbA1C2 Urine Sugar FUS PPUS REMARKS: No response Mild response Moderate response Marked response Signature of P.G Scholar Signature of Guide    
  • 195. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  DQOL Questionnaire Sl no. QUESTIONS SCORING I. PHYSICAL 1. How often do you feel physically ill? 1 2 3 4 5 2. How often do you have bad night sleeps? 1 2 3 4 5 3. To what extent do you have difficulty in performing 1 2 3 4 5 your routine activities? 4. How much are you bothered by any limitations in 1 2 3 4 5 performing everyday living activities? 5. How often do you feel fatigue? 1 2 3 4 5 II. PSYCHOSOCIAL 1. How satisfied are you with your social relationship? 1 2 3 4 5 2. How often do you feel good about yourself? 1 2 3 4 5 3. Do you get the kind of support from others that you 1 2 3 4 5 need? 4. How much do you experience positive feelings in your 1 2 3 4 5 life? 5. How well are you able to concentrate? 1 2 3 4 5 III. SEXUAL 1. How often does your diabetes interfere with your sex 1 2 3 4 5 life? 2. How satisfied are you with your sex life? 1 2 3 4 5 3. How often are you worried about your sexual life? 1 2 3 4 5 4. Are you bothered by any difficulties in your sex life? 1 2 3 4 5 5. How well are your sexual needs fulfilled? 1 2 3 4 5 IV. SATISFACTION IN LIFE 1. How satisfied are you with the quality of your life? 1 2 3 4 5 2. How much do difficulties with transport restrict your 1 2 3 4 5 life? 3. To what extent are you hopeful about your life? 1 2 3 4 5  
  • 196. Clinical Evaluation of Vatsakadi Qwatha in the Management of Madhumeha w.s.r to Diabetes Mellitus (NIDDM)  4. To what extent do you feel peaceful within yourself? 1 2 3 4 5 5. To what extent does faith contribute to your well-being? 1 2 3 4 5 V. TREATMENT SATISFACTION 1. How willing are you to take medications? 1 2 3 4 5 2. How much do you need any medication to function in 1 2 3 4 5 your daily life? 3. How dependent are you on medications? 1 2 3 4 5 4. How satisfied are you about the present treatment? 1 2 3 4 5 5. How confident are you with the outcome of the 1 2 3 4 5 treatment? HEALTH PERCEPTION* 1. Compared to others of your age would you say your E G F P VP health is