| CTRI Number |
CTRI/2025/07/090229 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of Bilwadi ghanvati in Obesity |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Bilwadi ghanvati in Medoroga with special refrence to obesity(class 1) |
| 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 Pooja Sodgir |
| Designation |
PG Scholar Kayachikitsa Dept. |
| Affiliation |
ASS, Ayurvedic Mahavidyala Nashik |
| Address |
Aarogyashala Rugnalaya panchavati Nashik
Aarogyashala Rugnalaya panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8805653302 |
| Fax |
|
| Email |
poojasodgir2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Garge |
| Designation |
Kayachikitsa Dept. |
| Affiliation |
ASS Ayurvedic Mahavidyala Nashik |
| Address |
Aarogyashala Rugnalaya panchavati Nashik
Aarogyashala Rugnalaya panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405366160 |
| Fax |
|
| Email |
drhgarge@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Sodgir |
| Designation |
PG Scholar Kayachikitsa Dept. |
| Affiliation |
ASS, Ayurvedic Mahavidyala Nashik |
| Address |
Aarogyashala Rugnalaya panchavati Nashik
Aarogyashala Rugnalaya panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8805653302 |
| Fax |
|
| Email |
poojasodgir2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarogyashala Rugnalaya ganeshwadipanchavati Nashik 422003,maharashtra ,india |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Purushottam Sodgir |
| Address |
Aarogyashala Rugnalaya ganeshwadipanchavati Nashik 422003,maharashtra ,india |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Purushottam Sodgir |
Arogyashala Rugnalaya |
kayachikitsa dept. OPD. No. 13,Aarogyashala Rugnalaya ganeshwadi,panchavati Nashik 422003,maharashtra ,india
Nashik
MAHARASHTRA |
8805653302
poojasodgir2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E755||Other lipid storage disorders. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwadi Ghanwati, Reference: sharangdhar sanhita madhyam khand, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhudodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala ghanavati, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient Having BMI Ranging Between 30-34.9kg/M2 I.E., Obesity
(Class 1)
2) Patient Between Age Group 20-50 Yrs ,Irrespective Of Gender.
3) Patient Having Sign And Symptoms Of Sthaulya Kshudra Shwas,
Kshudhatimatra,Pipasadhikya,Swedadhikya,Atinidra,Daurgandha
,Daurbalya.
4) Patients Of Both Gender
5) Patients Willing For Trial And Giving Written Consent |
|
| ExclusionCriteria |
| Details |
1) BMI less Than 30 and More Than 35
2) Patients is known case of cardiac , pulmonary,renal and hepatic
diseases, etc.
3) Patients having medical emergencies associated with like
Coronary Heart disease, Atherosclerosis, Myocardial infarction
etc.
4) Pregnant females and lactating women.
5) Patients having known case of diabetic mellitus, thyroid disorder
and HTN, and other endocrine disease.
6) Overweight due to drug eg. - corticosteroids.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Bilwadi ghanavati on reducing BMI in obesity (class 1)subjects. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study tolerance of Bilwadi ghanavati in Medoroga with respect to
obesity (class1) subjects for 90 days
To compare the effect of Bilwadi Ghanwati & triphala ghanavati in
weight reduction in obese (class 1) person
To compare the effect of Bilwadi ghanavati & triphala ghanavati in
Medoroga with respect to BMI in obese (class 1) person
To compare effect of Bilwadi ghanavati & triphala ghanavati on
lipid profile in Medoroga (obese class 1)
To compare effect of Bilwadi ghanavati & triphala ghanavati in
signs & symptoms of Medoroga |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 2 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Obesity is becoming major worldwide problem and growing day by day known as global epidemic and is the major and basic cause of lifestyle disorders like cardiovascular diseases, diabetes mellitus(T2DM), hypertension, stroke, musculoskeletal disorders, liver diseases, Cancer etc. In modern medicine there is no any effective medicine to control or permanent cure for obesity. Diet, moderate exercises and behavioural modification are first line management.Today it is need to find the drug which is cost effective, easily available everywhere and easy to follow one such preparation is Bilwadi kwath mention in Sharangdhar samhita having properties like kaphagna, medohara. Bilwadi kwath has Ushna, Laghu, Ruksha Guna and Deepana, Kapha-vata Hara and Medohara Karma expected to increase the power of Rasa and Meda Dhatvagni, decrease in Kapha and Vata and thus decrease in further formation of Aama, Meda Dhatu and its deposition in body results in an improvement in Medoroga. |