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1. • TITLE OF SYNOPSIS -
• Two arm open randomized controlled clinical study of efficacy of Agnimukha Churna (Gad
Nigraha) with Kapitthasthak churna (Vrunda Madhav) in the clinical management of
Grahani.
Vd.Ankita Ashok Patil
PG Scholar
Guide-
Vd.Mrs.Anaya Pathrikar
M.D.(Kayachikitsa)
Professor and H.O.D Dept.of Kayachikitsa
Institute
APM’S Ayurvedic Mahavidyalaya Sion Mumbai 400022
Year
2020-21

2. INTRODUCTION -
• अथ खलु त्रय उपस्तम्भाः इति - आहभर स्वप्नो ब्रम्हचययतिति| (charak sutra) is the basic sutra in
Ayurveda.Thus ahar should be given immense importance.
• सोन्नियाः पुरुषाः।Meaning Human gastrointestinal system, it’s well being is the result of
what food he eats.
• A detailed आहभर तिधी स्वरुप is given as - उष्णं स्निग्धं मात्रात् स्निर्णे स्निर्ाास्निुद्धमम् इष्ट देशे
• इष्ट सिोपकरर्णं नास्नतद्रुतं नास्नतस्निलम्बितम् अिल्पम् अहसन् तन्मना भुंस्नित,
• आत्मानमस्नभसमीक्ष्य सम्यक
् || (charak viman) these are ettiquets to be followed
• while having food. Which are not followed nowadays leading to Agnivikruti.
• As said, सिे रोगा मन्दास्ननलो.. (A H Udar Nidan)
• Also rightly said, …शान्तेअग्नौ स्निर्ते, र्ुक्ते स्निरञ्जीित्यनामर्ः।रोगीस्यास्निक्र
ु ते मूलं
अस्नग्नस्तस्माद् स्ननुदच्यते॥ (Charak chi 15/3)
• Impairment of agni leads to range of diseases and ultimately may even lead to death also
and if agni is good then human life becomes chirayu. Thus agni is the main base of healthy
life. While studying etiopathogenesis and treating patients of Grahani disease, it was crystal
clear that ‘Agnidushti’ needs to be treated for major recovery from Grahani disease. This
disease always fascinated me while undergoing my clinical training in UG. Hence I ll like to
work on Grahani organ the seat of Agni with the help of my combination.

3. Research Question
• 1)PRIMARY RESEARCH QUESTION
Does Agnimukha churna play any role in the management of Grahani?
• 2)Secondary Research Question
Does the treatment of Grahani with Agnimukh churna leads to decrease in
symptoms than that with Kapitthasthak churna or not ?
Hypothesis
• 1] Null Hypothesis (Ho) : Agnimukh Churna does not have any role in the management
of Grahani.
• 2] Alternate Hypothesis –
1)Agnimukh churna is more effective than Kapitthasthak churna in the
management of Grahani
2)Other Hypothesis - Kapitthasthak churna is more effective than
Agnimukh churna in the management of Grahani.

4. AIM - To compare efficacy of Agnimukha churna and Kapitthasthak churna in
the clinical management of Grahani.
OBJECTIVES –
1]PRIMARY OBJECTIVE –
1.To evaluate the efficacy of Agnimukh churna in Grahani.
2]SECONDARY OBJECTIVE –
To compare efficacy of mode of action Agnimukha churna and Kapitthasthak
churna in Grahani
3]OTHER OBJECTIVE –
1. To study grahani disease and treatment in detail.
2. To study the literature of Grahani from the ayurvedics refrences.
3. To access adverse effect of Agnimukha churna and Kapitthasthak churna; if
any.
.

5. Methodology –
Type of study design
• Open Randomized controlled clinical study.
• Study centre of OPD and IPD of Ayurvedic Rugnalaya.
Duration of study
• Duration of drug administration - 28 days
• Total duration of study and observation -18 to 20 month
Study population and Sample size - Total number of patients-60
divided in 2 group of 30 patients in each group.

6. METHOD OF SELECTION OF STUDY SUBJECTS -
1]INCLUSION CRITERIA :
Patients between 16-60 years of all the genders..
Patients having lakshanas of Grahani.
For.eg : Aruchi, Kshudhamandhya, Bahudravasaranam, Murhubaddham murhudravam,
Udardaha.
2] EXCLUSION CRITERIA :
• Pregnant women & lactating mothers.
• Patients suffering from bleeding diseases.
• Patients with disorders like HIV,Koch’s that would interfere with the course of the study.
Patient who are on steroids treatment.
• Patients who do not give consent for treatment.
3] WITHDRAWAL CRITERIA :
• If any adverse drug reaction is seen in the patient.
• If patient loses two consecutive follow ups.
• If the patient is not willing to continue the treatment.

7. Subjective Parameter -
• Aruchi
• Mal Vaat durgandha
• Aantrakujanam
• Gouravta, Kshudhamadhya
• Udarshul/Kukshishul , Aadhman
• Udardaha, Murhu drava murhu baddham
• Picchil Mal
Following gradation and scoring are taken as subjective parameters to study the
effect of drug.
Grade 0-nil
Grade 1-mild
Grade 2-moderate
Grade 3-severe
Objective parameters
● Modified IZUMO scale
● Bhara (weight)

8. 1] Agnimukha Churna - (Drug 1 Trail group)
स्नत्रकटू स्नत्रफलाभागाः पंि षट् ि पॄथक
् िव्यस्नित्रकर्,
स्निडसैंधि सौििालमेकस्निस्नत्रर्णी कषाास्नर्ण॥
इस्नत िूर्णं ग्रहर्णी गदम् गुदिोदरगुल्मशुलघ्नम्।
िनर्स्नत ि िातिेदसमल्पमभुिामेतदग्नीमुखम्॥
- Gada Nigraha

9. Dravya proportion
• Trikatu = 5 parts
• Trifala = 5 parts
• Chavya = 6 parts
• Chitrak = 6 parts
• Beedlavan = 1 parts
• Saindhav = 2 parts
• Souvarchal = 3 parts

10. 2] कस्नपत्थाष्टक िुर्णा – (Control Group)
र्िानी स्नपप्पलीमूलितुािातनागरः।
मररिास्नग्निलािािी धान्यक सौििालः समः॥
िॄक्षाम्लधातकीक
ॄ ष्णास्निल्वदास्नडम स्नदप्यकः।
स्नत्रगुर्णषड्गुर्णस्नसतः कस्नपत्थाष्टगुनः क्र
ु तः।
िुर्णोअस्नतसारग्रहर्णी क्षर्गुल्मगलामर्ान्।
कासश्वास अस्नग्नसादाशाः पीनसारोिकाञ्चर्ेत्॥
-Vrundamadhav Grahani Chikitsa

11. Dravya proportion
• Yavani, Pippalimul, Tvak, Ela,
Tamalpatra, Nagkeshar, Shuntha,
Marich, Ajaaji, Dhanyak, Souvarchal,
Chitrak, Ushir - All are taken in equal
parts.
• Vrukshamla, Dhatki,Krushna, Bilva,
Dadim, Deepyak – 3 times of above
• Sita – 6 times
• Kapitha – 8 times

12. Group Group A
Trial group
Group B
Control group
No. of subject 30 Patients 30 Patients
Drug Agnimukha churna Kapitthasthak churna
Duration of study 28 days 28 days
Dose 3 gm twice daily 3gm twice daily
Route of administration Oral Oral
Anupana Ushnodaka Ushnodaka
Kaala Prakbhakta
(Before food)
Prakbhakta
(Before food)
RESEARCH METHODOLOGY

13. Follow up
1st follow up - 7th day
2nd follow up - 14th day
3rd follow up - 21th day
4th follow up - 28th day
Drug authentication and standardisation –
The ingredients of the medicines will be procured from
market and certificate of authenticity of drug will be
obtained from certified authorities.

14. Data management and Analysis
procedure
• Observation of the data in the clinical study will be
presented in the suitable table and graphs where
necessary.The results of the trail drug for the study
will be analyed statistically using appropriate test.
• Collected data will be presented in the form of tables
and charts.
• For subjective data – Mann Whitney U test
• For objective data – Unpaired T test

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Task 1
Task 2
Task 3
Task 4
Task 5
Gantt chart

16. •Task 1:
Drug & Disease Review-
Review of drug and disease will be taken from an ancient ayurvedic classical text
and from modern literature, research paper, research articles.
•Task 2:
Collection &preparation of drug-
Raw material drugs of “Agnimukh churna” and “Kapitthasthak churna” will be
collected from the authentic source after validation of samples.
•Task 3:
Drug Authentication & Standardization-
Authentication and standardization will be done from certified authorities.
•Task 4:
Clinical Trial-
Screening of patient’s assessment, enrolment, drug administration & follow up’s of
patients will be done with documentation.
•Task 5:
Statistical Analysis-
Collected data will be presented and statistical analysis & interpretation of
results will be done.

17. • DISCUSSION :-
Discussion will be done on the basis of collected data and statistical
analysis.
• CONCLUSION :-
Strictly based on the observation and result of statistical analysis.
•SUMMARY:-
On the basis of observation and discussion,Summary of
total clinical trials carried out.

18. Thank you