| CTRI Number |
CTRI/2025/09/095423 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is Vidang powder an effective Natural treatment for Mild obesity? |
|
Scientific Title of Study
|
A Comparative Study To Evaluate The Efficacy Of Vidang Beej Churna (Embelia ribes) In Sthaulya ( Class 1 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 |
Abhilasha |
| Designation |
PhD Scholar |
| Affiliation |
SGT UNIVERSITY, GURUGRAM, HARYANA |
| Address |
Room no 7
Department of Dravya Guna
FIMS D BLOCK
SGT UNIVERSITY
Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
9905012340 |
| Fax |
|
| Email |
dean.fims@sgtuniversity.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anil kumar Sharma |
| Designation |
Dean FIMS SGT UNIVERSITY |
| Affiliation |
SGT UNIVERSITY, GURUGRAM, HARYANA |
| Address |
Dean office
FIMS
SGT UNIVERSITY
Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
9416085092 |
| Fax |
|
| Email |
anilherbals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhilasha |
| Designation |
PhD Scholar |
| Affiliation |
SGT UNIVERSITY, GURUGRAM, HARYANA |
| Address |
Room no 7
FIMS
Department of Dravya Guna
SGT UNIVERSITY
Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
9905012340 |
| Fax |
|
| Email |
dean.fims@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| GS AYURVEDA MEDICAL COLLEGE & HOSPITAL PILKHUA Hapur UP |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Abhilasha |
GS Ayurveda Medical College And Hospital Pilkhuwa UP |
Room no.8 Dept of Medicine
GS Ayurveda Medical College And Hospital Pilkhuwa UP
Meerut
UTTAR PRADESH |
9905012340
drabhilasha29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commiittee of SGT University, Gurugram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient with higher BMI and elevated lipid profile |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Embelia ribes , Reference: Ashtang Hriday Sutra2/15, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Udhwartana will be done by Vidang Churna | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Embelia ribes, Reference: Charak Sutra Sthan 21/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH HIGHER BMI AND ELEVATED BMI |
|
| ExclusionCriteria |
| Details |
Patient who have systemic disorders like diabetes hypertention cancer etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There is significant difference in the effect of vidang churna
application( external+internal) on obesity i.e. elevated BMI |
Trial Duration 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/11/2025 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drabhilasha29@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2028?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Atisthaulya is one of the oldest documented metabolic disturbance in Ayurveda associated with obesity. In Ayurvedic literature, Ati-sthaulya has been described not as obese state only rather than a clustering of pathological events induced by obesity.Vidanga (Embelia Ribes) is one of the important herb that has been described in Charak Samhita to treat Atisthoulya. This study aims at providing scientific evidences behind such use of Vidanga (Embelia Ribes). Research Objective To study the disease obesity clinically & comprehensively in the light of the description available in Ayurveda & modern medicines. To evaluate anti-obesity potential of Embelia ribes . To assess the comparative efficacy in external or internal use of vidang churna. To prevent patients from obesity and to help them to spend a healthy life with no comorbidity. |