Title of synopsis

• A 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
 Introduction
• अथ खलु त्रय उपस्तम्भाः इति - आहार स्वप्नो भ्रम्हचर्यमिति। (charak sutra) is the
basic sutra in Ayurveda.
• सोन्नमयः पुरुषः।
• आहार विधी स्वरुप - उष्णं स्निग्धं मात्रात् जिर्णे विर्याविरुद्धम् इष्ट देशे इष्ट सर्वोपकरणं नातिद्रुतं
नातिविलम्बितम् अजल्पम् अहसन् तन्मना भुंजित, आत्मानमभिसमीक्ष्य सम्यक् || (charak
viman) these are ettiquets to be followed while having food.
• सर्वे रोगा मन्दानिलो.. (A H Nidan)
• शान्तेअग्नौ म्रियते, युक्ते चिरञ्जीवत्यनामयः।
रोगी स्याद्विक्रु ते मूलं अग्निस्तस्माद् निरुच्यते॥
Impairment of agni leads to range of diseases and ultimately to death also and if
agni is good then human life increases.Thus agni is the main base of healthy life.
Research Question
• 1)PRIMARY RESEARCH QUESTION
Does Agnimukha churna play any role in the management of Grahani?
• 2)Secondary Research Question
Does Kapitthasthak churna play role in the management of Grahani?

Hypothesis
• 1)Primary Hypothesis : Agnimukh Churna and Kapitthasthak churna does not have any effect
in the management of Ajeerna(Indigestion)
• 2]Secondary 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.
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.To study efficacy of Kapitthasthak churna in grahani.
2]SECONDARY OBJECTIVE –
1.To compare efficacy of mode of action Agnimukha churna and Kapitthasthak churna in
Grahani
3]OTHER OBJECTIVE –
1. To give practical approach to parameters of grahani like Annam Ghrunhati Pachati
Vivechayati Munchati.
2. To study the literature of Grahani from the ayurvedics refrences.
3. To access adverse effect of Agnimukha churna and Kapitthasthak churna; if any.
.
 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.
 METHOD OF SELECTION OF STUDY SUBJECTS:
1]INCLUSION CRITERIA :
Patients between 16-60 years of age.
Patients having lakshanas of Grahani.
For.eg : Aruchi, Kshudhamandhya, Bahudravasaranam, Murhubaddham
murhudravam.
2] EXCLUSION CRITERIA :
• Pregnant women & lactating mothers.
• Patients suffering from infectious diseases.
• Patients who has acute or chronic blood loss.
• Patients with systemic disorders that would interfere with the course of the study.
• 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.
 Subjective parameters
•Aruchi
•Mal Vaat durgandha Following gradation and scoring are
•Aantrakujanam taken as subjective parameters to
study the effect of drug.
•Gouravta, Kshudhamadhya
Grade 0-nil
•Udarshul/Kukshishul , Aadhman Grade 1-mild
•Udardaha, Murhu drava murhu Grade 2-moderate
Grade 3-severe
baddham
•Picchil Mal
Objective parameters
● Modified IZUMO scale
● Bhara (weight)
1] Agnimukha Churna - (Drug 1 Trail group)

त्रिकटू त्रिफलाभागाः पंच षट् च पॄथक् चव्यचित्रकय,

बिडसैंधव सौवर्चलमेकद्वित्रिणी कर्षाणि॥
इति चूर्णं ग्रहणी गदम् गुदजोदरगुल्मशुलघ्नम्।
जनयति च जातवेदसमल्पमभुजामेतदग्नीमुखम्॥
- Gada Nigraha
 Dravya proportion
Trikatu = 5 karsha
Trifala = 5 karsha
Chavya = 6 karsha
Chitrak = 6 karsha
Beedlavan, Saindhav, Souvarchal = 12
karsha each
2] कपित्थाष्टक चुर्ण – (Control Group)

यवानी पिप्पलीमूलचर्तुजातनागरैः।
मरिचाग्निजलाजाजी धान्यक सौवर्चलैः समैः॥
वॄक्षाम्लधातकीकॄ ष्णाबिल्वदाडिम दिप्यकैः।
त्रिगुणषड्गुणसितैः कपित्थाष्टगुनैः क्रु तैः।
चुर्णोअतिसारग्रहणी क्षयगुल्मगलामयान्।
कासश्वास अग्निसादार्शः पीनसारोचकाञ्चयेत्॥
-Vrundamadhav Grahani Chikitsa
 Dravya proportion
Yavani, Pippalimul, Tvak, Ela,
Tamalpatra, Naagkeshar, Shuntha,
Marich, Ajaaji, Dhanyak, Souvarchal,
Agni, Jaal - all are taken in equal parts.
Vrukshamla, Dhatki,Krushna, Bilva,
Dadim, Deepyak – 3 times
Sita – 6 times
Kapitha – 8 times
 Research methodology
Group Group A Group B
Trial group 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 3gmtwice daily

Route of administration Oral Oral

Anupana Ushnodaka Ushnodaka

Kaala Prakbhakta Prakbhakta

(Before food) (Before food)
 Follow up
1st follow up - 7th day
2nd follow up - 14th day
3rd follow up - 21th day
4th follow up - 28th day
 Gantt chart

2021 2022 2022

Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun

Task 1

Task 2

Task 3

Task 4

Task 5
•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.
•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.
Thank you