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CTRI Number  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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Metformin500mg OD or BID
2Intervention ArmDrugClassical(1) Medicine Name: Varadarvadi Ghanavati, Reference: Sharangdhar Samhita, Madhyamkhanda, 2/108, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
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