CTRI/2025/03/083524 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On:
24/03/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To study the effect Varadarvyadi Ghanavati in the management of Diabetes Mellitus.
Scientific Title of Study
A controlled clinical study to evaluate the efficacy of Varadarvyadi Ghana Vati as an adjuvant drug to metformin in the management of Prameha with special reference to Type 2 Diabetes Mellitus
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Aditya Hemant Redij
Designation
PG SCHOLAR
Affiliation
R A PODAR AYURVED MEDICAL COLLEGE WORLI, MUMBAI
Address
room no. 4, PG boys hostel, M.A. Podar Hospital DR. ANNIE BASANT ROAD, WORLI, MUMBAI - 18 Mumbai MAHARASHTRA 415609 India
Phone
07972926429
Fax
Email
adityaredij89@gmail.com
Details of Contact Person Scientific Query
Name
DR MEENAKSHI SUBHASH REWDKAR KOLE
Designation
ASSOCIATE PROFESSOR
Affiliation
R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI
Address
OPD No 18, Kayachikitsa department, M A Podar Hospital,R A Podar Govt (Ayu) College DR. ANNIE BASANT ROAD, WORLI, MUMBAI - 18 Mumbai MAHARASHTRA 400018 India
Phone
9757476325
Fax
Email
drmrevadkar@yahoo.com
Details of Contact Person Public Query
Name
DR MEENAKSHI SUBHASH REWDKAR KOLE
Designation
ASSOCIATE PROFESSOR
Affiliation
R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI
Address
OPD No 18, Kayachikitsa department, M A Podar Hospital,R A Podar Govt (Ayu) College DR. ANNIE BASANT ROAD, WORLI, MUMBAI - 18 Mumbai MAHARASHTRA 400018 India
Phone
9757476325
Fax
Email
drmrevadkar@yahoo.com
Source of Monetary or Material Support
OPD No 18, Kayachikitsa department, M A Podar Ayurved Hospital, Worli ,Mumbai PINCODE 400018 country - India
Primary Sponsor
Name
R A Podar Government Ayurved College Worli Mumbai
Address
R A Podar Government (Ayu) College Worli Mumbai 18 Dr Annie Basant Road Worli Mumbai
400018
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Aditya Hemant Redij
Mahadevi Anandilal Podar Goverment Hospital
OPD No 18 Kayachikitsa department M A Podar Hospital R A Podar Government (Ayu) College Worli Mumbai 18 Mumbai MAHARASHTRA
7972926429
adityaredij89@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
BORS COMMITTEE OF INSTITUTION, R A PODAR GOVERNMENT AYU COLLEGE, WORLI
1. Subjects who are willing to give written informed consent.
2. Patients having signs & symptoms of Prameha like Prabhutmutrata (Polyuria), Pipasadhikya (Polydipsia), Kshudhaadhikya (increased meals), Mutramadhurya (Glycosuria), Swedadhikya (Profuse sweating).
3. Patients having BSL (F) = 126 - 250 mg/dl (PP) = 250 - 350 mg/dl
4. HbA1c level = 6.5 - 10%
5. The patient of hyperglycemia along with clinical symptoms.
ExclusionCriteria
Details
1. Patient taking or requiring OHA other than metformin
2. Patient having IDDM, Juvenile Diabetes Mellitus, Gestational Diabetes Mellitus, diabetes with complications, Ketoacidosis, Drug induced Diabetes like use of glucocorticoid, thiazide diuretic etc.
3. Pregnant & lactating women
4. Hepatitis B, Hepatitis C, AIDS, Tuberculosis, CA or any other immunocompressive disorder and major life threatening diseases.
5. Patient with IHD, Kidney disease, CVA (Hemiplegia)
6. Patient on immunosuppressive therapy, on antidepressant agents, patient with hypothyroidism or hyperthyroidism.
7. Mentally retarded, Psychologically unstable and non-cooperative patients.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at 4th week, 6th week, 8th week, 10th week and 12th week.
2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati with 12 weeks of duration
3) To study the effect of ‘Varadarvyadi Ghanavati’ on BSL, HbA1c after 12 weeks.
1) To study the effect of in‘Varadarvyadi Ghanavati’ the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at the time of 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week
2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati after 12th week.
3) To study the effect of ‘Varadarvyadi Ghanavati’ on BSL, HbA1c after 12 weeks.
Secondary Outcome
Outcome
TimePoints
1) To review the Ayurvedic & Modern literature on Type 2 Diabetes Mellitus. 2) To correlate Prameha vyadhi and Type 2 Diabetes Mellitus. 3) To asses the possible mode of action of Varadarvyadi Ghanavati.
At 2nd, 4th, 6th, 8th, 10th and 12th week
Target Sample Size
Total Sample Size="90" Sample Size from India="90" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
10/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Ayurveda is an ancient system of medicine having roots in the Indian Subcontinent. The aim of Ayurveda is prevention of disease, prolongation of healthy life, to help a person to attain the four principle of life that is Dharma, Artha, Kama, Moksha. Ayurveda provides optimal health and wellbeing through a comprehensive approach that addresses mind, body, behavior and environment.
Prameha is described as one of the Ashtamahagada in ayurveda samhita. Prameha which has been a global problem is described in ancient Indian classics like Charak Samhita, Sushruta Samhita, Ashtanga Sangraha, Ashtanga Hridaya, Yogratnakara etc. It’s described thoroughly as etiology, pathogenesis, prognosis, complications, it’s management. The Indian ancient samhitas also describe the relationship of dietary, lifestyle, environment and genetic factors. The Prameha which was described as mahagada in ancient time is still difficult to treat in 21st century.
The pathogenesis of Prameha indicates that vitiated Three Doshas (vata, pitta, kapha) and Ten Dushyas (rasa, rakta, mansa, meda, majja, shukra, lasika, vasa and ooj) are responsible for development of Prameha according to Ayurveda. The main dosha is vitiated kapha dosha is responsible in the samprapti of Prameha (kaphakrut ch sarvam). Acharya described 20 types of Prameha on the basis of predominance of dosha and appearance of mutra(urine).
In this era of globalization, lifestyle is changing everyday. The living habits, eating habits of people are changing day to day. Irregular food intake, lack of exercise, excessive stress, work life imbalance, disturbed sleep pattern eventually affect the metabolism of human body. These give rise to lifestyle disorders. Diabetes is characterised by hyperglycemia i.e. raised blood glucose level developing the symptoms like polydipsia, polyphagia, polyuria, nocturia, Fatigue etc. The prevalence of diabetes in India in adults is estimated to be 11.3%.
Ayurveda samhitas have such wonderful formulations. The kalpa varadarvyadi ghanvati is described in sharangdhara samhita. The contents of this kalpa are 1)vara(triphala), 2)darvi(daruharidra), 3)musta, 4)deodaru.
This combination of drugs mentioned above helps in sampraptibhanga of prameha and is easy to available. Taking all this consideration the study is taken up entitled “A controlled clinical study to evaluate the efficacy of ‘Varadarvyadi Ghanavati’ in the management of Prameha with special reference to Type 2 Diabetes Mellitus.
Scope of study :-
Though we have the tremendous medicines, modern medicine shows limitations in the management of metabolic diseases. Hence we are moving towards ayurvedic approach.
In India, prevalence of diabetic population is high. Diabetes mellitus hampers cellular components of organ or entire system. Diabetes is going to be a major health issue due to its serious complications. In the management of DM with modern medical science, we have to face related complications like GI upset, nausea, diarrhea, lactic acidosis etc. Here, ayurveda provides as an adjuvant therapy to modern medicine. Thus, there is need of clinical research in getting a hold on this disease not only to achieve good glycemic control but also to treat the root cause.
Number of patients :-
Group A: Study group - 45 patients will be administered Varadarvyadi Ghanavati along with Metformin.
Group B: Control group - 45 patients will receive only Metformin.
Investigations :-
Blood CBC, ESR, BSL fasting and PP, Liver Function and Renal Function Test, Lipid Profile to exclude any Pathology.
Glycosylated Hemoglobin(HbA1C) test will be estimated before and after treatment.
Summary and Conclusion:
The work will be summarized to make final conclusions.
Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.
Expected outcomes:
? Changes in subjective by ’Varadarvyadi Ghanavati’ towards reduction in previous severity.
? Changes in Glycosylated Hemoglobin(HbA1C) by ’Varadarvyadi Ghanavati’ towards reduction of Fasting and Post Prandial Blood Sugar Level.