| CTRI Number |
CTRI/2025/06/088974 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to see how Bilwadi kwatha and healthy lifestyle changes can help manage obesity |
|
Scientific Title of Study
|
An open randomized clinical trial to evaluate the effect of Bilwadi Kwatha and Lifestyle modification in the management of Sthaulya(Obesity) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
Principal-cum-Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) |
| Address |
Hospital building room no. 317
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola Kangra HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Soni |
| Designation |
Senior Lecturer |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) |
| Address |
Hospital building room no. 317
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816842425 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajan Verma |
| Designation |
MD Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) |
| Address |
Hospital building room no.317
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018159533 |
| Fax |
|
| Email |
sajanverma1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak pharmacy
Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola , Kangra |
|
|
Primary Sponsor
|
| Name |
Dr Vijay Chaudhary |
| Address |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola Kangra HP 176115 |
| Type of Sponsor |
Government medical college |
|
|
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 Sajan Verma |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) 176115 |
hospital building room no. 317
Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra (H.P.) 176115
Kangra
HIMACHAL PRADESH |
07018159533
sajanverma1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwadi Kwatha, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: Brham mhurat jagrana, vyayam, santulit ahaar vihaar, Ritucarya: follow all ritucharya , Acara Rasayana:follow all achar rasyana, Other:, Pathya/Apathya:yes, Pathya:low fat / low carbohydrate diet, balanced diet, Apathya:more fat / carbohydrate diet |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having BMI more than 25 will be included in the study
Raised waist hip ratio more than 0.8.
Patient of either gender in the age group between 18 to 60 years.
Patients present with symptomatology of Sthaulya obesity as described in Ayurvedic and modern literature.
(v) Willing to participate and able to provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
Obesity due to endocrine disorder
Patients having malignant disorder.
Patients having uncontrolled Type II Diabetes Mellitus.
Patients having uncontrolled Hypertension.
Patients who has completed participation in any other clinical trial during the past 3 months.
Any condition which the investigator thinks may compromise with the safety of the subject.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in waist circumference
Change in body fat percentage
Improvement in metabolic parameters e.g. blood sugar and cholesterol levels
Improvement in appetite control or digestion |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety of Bilwadi Kwatha in the management of obesity. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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 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
|
This trial will evaluates the effectiveness of Bilwadi Kwatha and lifestyle changes in managing obesity, focusing on weight reduction, metabolic improvement, and overall health in individuals with obesity. |