Ayur research vision 2020
Upcoming SlideShare
Loading in...5
×
 

Ayur research vision 2020

on

  • 1,205 views

Ayurveda Research Vision 2020 by Ayurmitra Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/

Ayurveda Research Vision 2020 by Ayurmitra Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
Guest lecture at DrBRKR GAC, Hyderabad, Andhra Pradesh, on 26-03-14

Statistics

Views

Total Views
1,205
Views on SlideShare
498
Embed Views
707

Actions

Likes
1
Downloads
16
Comments
1

5 Embeds 707

http://technoayurveda.wordpress.com 665
https://technoayurveda.wordpress.com 37
http://technoayurveda.com 3
https://www.google.co.in 1
http://translate.googleusercontent.com 1

Accessibility

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
  • My best wishes & regards for such a vision for ayurvedic research.
    i wish we could understand and incorporate dis vision to get some results upto 2020..........
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Ayur research vision 2020 Ayur research vision 2020 Presentation Transcript

  • Ayurveda Research Vision 2020 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 “Research is creating new knowledge.” -Neil Armstrong
  • Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Is Ayurveda Research is necessary? Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ “Research is formalized curiosity. It is poking and prying with a purpose. ” -Zora Neale Hurston What for we have to do Research? 1) To conform the past experiences 2) To exclude the selected past not relevant to the present 3) To include the new concepts /medicines / procedures / experiences 4) To include new herbs in to Ayurveda
  • Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Problems associated with clinical trials of Ayurvedic medicines Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Ashish K Sharma et.al., Problems associated with clinical trials of Ayurvedic medicines, Rev. bras. farmacogn. vol.20 no.2 Curitiba Apr./May 2010, http://dx.doi.org/10.1590/S0102-695X2010000200023  Integrated approach of many herbal systems does not differentiate the disease from the patient.  Ayurveda proposes different interventions at different stages of disease in the same patient providing another difficult to control variable in a clinical trial.  Herbal medicines used in traditional systems are used in the humans without any toxicity studies, their embryotoxic, foetotoxic, and carcinogenic effects are likely to remain unrecognized in traditional practice  With Ayurvedic medicines, it is difficult to plan double-blind randomized clinical trials. For clinical evidence of safety and efficacy the placebo-controlled, double blind randomized trial may be considered as gold standard,
  •  "there is no scientific evidence to prove that Ayurvedic medicine can treat or cure Cancer". - Cancer Research UK,  "Most clinical trials of Ayurvedic approaches have been small, had problems with research designs, or lacked appropriate control groups, potentially affecting research results.“- U.S. National Institutes of Health states  Ayurvedic drug manufacturers believe that GMP / GCP are not practical and should not applied to Ayurvedic drugs, as it would involve a huge amount of cost.  http://en.wikipedia.org/wiki/Clinical_trials_on_Ayurvedic_drugs Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  •  Ayurvedic parameters like Tridosha, Panchamahabhuta, Agni, Guna, Veerya, Vipaka, Prabhava, Avarana, etc. have to be taken in to account along with contemporary scientific parameters in the research of Ayurveda  Inclusion and exclusion criteria, end points, markers and methodology should be based on ASU philosophy  Clarity and Guidance for compliance on issues like active ingredients, chemical names, impurity profile, excipients, etc. also to be provided. Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Nagesh Sandu, AYUSH GCP : INDUSTRY PERSPECTIVE, Director Sandu Brothers Pvt Ltd Mumbai
  • What are the challenges faced during Clinical trials of Ayurvedic and traditional medicines? Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Formulations: It can be challenging to know which components are having an effect and why.  Interactions: Whenever two or more medications are used, there is the potential for them to interact with each other.  Scientific evidence.: Most clinical trials are small, had problems with research designs, lacked appropriate control groups, or had other issues that affected how meaningful the results were.
  • Facts Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  "Of the 166 plants investigated, 72 (43%) had at least one or more human studies and 103 (62%) had one or more animal studies. These results appear to contradict  There are difficulties in estimation of "active" molecules in body fluids in the pharmacokinetic studies in phase I of drug development especially in Ayurvedic formulation.  Storage conditions can also alter the bioavailability of herbal medicines, which may lead to loss of activity, fungal or bacterial contamination
  • Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Avoid the herbs have been reported to be poisonous in planning of clinical trials  Ayurvedic HMPs (Herbal Medicinal Products) are marketed as dietary supplements (In the west)  Many a times the medicine system advocates other procedures along with oral therapy which again may or may not be standardized.  crude raw herb material has number of variations as per geographical locations, climatic conditions, environmental hazards, harvesting methods, collection protocols, etc  Thus - a uniform research policy in herbal medicines is need of the hour. Ashish K Sharma et.al., Problems associated with clinical trials of Ayurvedic medicines, Rev. bras. farmacogn. vol.20 no.2 Curitiba Apr./May 2010, http://dx.doi.org/10.1590/S0102-695X2010000200023
  • Guidelines for ASU Drugs Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Ayurveda drugs Manufactured in accordance with formulae as per the definition given in clause (a) of Section 3 of the Drugs and Cosmetics Act, 1940.  Indian Ethno-medicines based drugs not covered under Categories I and II IV. Medicines based on extracts of medicinal plants of India
  • GUIDELINES FOR PRE-CLINICAL SAFETY EVALUATION FOR AYURVEDA Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  SUB-CHRONIC TOXICITY TESTS  Observations and examinations,  General signs, body weight and food and water intake  Hematological examination  Renal and hepatic functions tests  Recovery from toxicity
  • Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • DATA REQUIRED TO BE SUBMITTED WITH APPLICATION FOR PERMISSION TO CONDUCT CLINICALTRIALS ON AYURVEDA Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Information on the formulation (s)  2.1 Composition  2.2 Dosage from  2.3 Rational with relevant reference  2.4 Method of Manufacture  2.5 Standardization Parameters  Experimental Pharmacology (as the requirement may be)  3.1 General pharmacological actions  3.2 Specific pharmacological actions  Safety data (as the requirement may be)  4.1 sub-chronic  4.2 Genotoxicity if required (as per Schedule Y).  Investigator brochure, Protocol, Case Report Form, Patient Information Sheet, Informed consent form (English and local language) Footnote: The principle rules were published in the Gazette of India vide notification number F. 28-10/45-H (I), dated the 21st December, 1945 and subsequently amended vide notification number: - (1) GSR 755 (E) dt. 23.10.2008
  • OBJECTIVES Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Research on Fundamentals of Ayurveda, its principles and practices including Literature Research  Clinical research: Validation of clinical efficacy of Classical Ayurvedic Formulations on priority basis including Ayurvedic Diagnostics and Preventive Health Care.  Drug Research and Development based on Ayurvedic principles and Experimental leads
  • PRIORITY AREAS Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Fundamental Research i. Tridosha, Prakriti, Agni, Dhatu, Ojas, Srotas, Ama, Samprapti & Khad Kriya-Kala etc. ii. Rasa, Guna, Virya, Vipaka and Prabhava iii. Literature Research; Survey, collection, transcription / translation and preparation of classical literature and text books, Medico- historical investigations of Ayurveda
  • Selection of topic Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Drug Research and Development  i. Standardization and Quality Assurance  ii. Pharmaceutical Research and Development  iii. Pharmacology [In-vitro & in-vivo methods]  iv. Biomarker based Mechanism of action  v. Ethno-medicinal Research: survey and documentation of medicinal plants/practices etc.  vi. Veterinary Ayurveda products
  • Clinical Research Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Broad Areas  Development of Methods and modalities for Ayurvedic Clinical research  Development of protocols for Clinical Trials  Epidemiological Research  Promotive and Preventive Health Care  R & D on Ayurvedic Diagnostics( including Prakriti and Nadi Pariksha)  R & D on Panchakarma and standardization of its procedures.
  • Diseases /Areas based on strength of Ayurveda, National priorities i. Preventive Cardiology Atherosclerosis Hypertension Dyslipidemia ii. Gastro intestinal disorders Hepatic Disorders Diarrhoeas and Chronic Enteropathies iii. Musculo-skeletal disorders Osteoporosis Osteoarthritis Rheumatoid Arthritis iv. Eye diseases Diabetic Retinopathy Computer Vision syndrome v. Metabolic Syndrome and obesity vi. Diabetes Mellitus vii. Skin diseases viii. Respiratory diseases ix. Generalized Anxiety Disorder x. Anaemia xi. Malaria xii. BPH, Urolithiasis xiii. Fistula-in-ano, Para-surgical procedures xiv. Neurological disorders and Neuro- degeneration xv. Rasayana therapy& Geriatrics xvi. Reproductive & Child Health xvii. Quality of life (QOL) in cancer patients Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • METHODOLOGY AND APPROACH Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Phase- I: Healthy volunteers or subjects (20-100). Not required for classical Ayurvedic formulations. This phase may be conducted on case to case basis, wherever required.  Phase- II & III: Subjects (several hundred), direct phase II &III studies will be conducted.  Phase- IV: Subjects in select disease conditions (Several hundred to several thousand for assessing quality of life). This phase may be conducted on case to case basis, wherever required.
  • Statutory, Ethical and Research guidelines: Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Clinical trials should follow the prevalent statutory, ethical and research guidelines like GCP guidelines prevalent in India and the collaborating centres and these trials will be registered with Clinical Trial Registry of India (CTRI).
  • Preclinical studies: Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Though the Preclinical studies on the Ayurvedic classical formulations is not necessary since they are in use for many years.  However, pre-clinical studies will be conducted on these formulations on case to case basis.  Quality control studies and pre clinical Safety/toxicity studies will be conducted at CCRAS & PLIM and outsourced through NABL/GLP compliant laboratories.
  • Procurement of trial drugs: Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Trial drugs for the projects will be procured from CCARS peripheral institutes and reputed GMP compliant industries.  IMPCL/PLIM/ any state government undertaking will also be one of the sources for trial drugs.
  • Levels of Evidence Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Evidence Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
  • Need of new research methodology for Ayurveda Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  EBM clinical trial regimens limit the use of Prakriti, Dosha Anubandha- Anubandhyatwa, Arambhaka and Anugami Dosha Vikalpa, Swanidana Prakopa Awaranajanya Prakopa, Prakriti SamaSamveta-Vikritishamasamveta, Amavashthapakvavastha, which leads to variation of dose, dosage form, Aushadhikala, Anupana, Sahapana, Pathyapathya, therapeutics like Panchakarma procedures to be adopted, etc. M. S. Baghel http://www.ayujournal.org, AYU | Jan-Mar 2011 | Vol 32 | Issue 1
  • The clinical trials in Ayurveda are needed for– Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  Revalidation of facts enumerated in Ayurvedic classics leading to the explanation of fundamental principles;  to find out better treatment modalities for the existing diseases and for newer diseases;  to standardize the treatment procedures scientifically and  to establish dose, duration, indication and side-effect profile of any given drug. M. S. Baghel http://www.ayujournal.org, AYU | Jan-Mar 2011 | Vol 32 | Issue 1
  • CTRI registration Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/  The Clinical Trials Registry - India (CTRI), an online system (www.ctri.nic.in) for the registration of clinical trials being conducted in India, has its secretariat at the National Institute of Medical Statistics of the Indian Council of Medical Research in New Delhi.  You may reach this site from Gateway of – www.technoayurveda.com  The CTRI performs quality assurance on submitted entries, and has a mechanism for obtaining updated data and as well as performs de-duplication of submitted trials.
  • Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14
  • Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14 Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/