| CTRI Number |
CTRI/2025/12/099622 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of triphala,Vacha and musta Tablet on Body Weight in Obese Children |
|
Scientific Title of Study
|
Assessing the Efficacy of Oral Administration of Triphala, Vacha, and Musta Combination Tablet in Childhood Obesity (Sthaulya):A Double-Blind, Placebo-Controlled Randomized Trial |
| 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 Deepak Sah |
| Designation |
Pg Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no-406, Seminar room , Dept. of Kaumarabhritya and Bala Roga ,All india Institute of Ayurveda
Mathura Road,Gautampuri, sarita vihar,Delhi
South
DELHI
110076
India |
| Phone |
9717389679 |
| Fax |
|
| Email |
deepakkumar040496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahapatra Arun kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no-409, Seminar room , Dept. of Kaumarabhritya and Bala Roga ,All india Institute of Ayurveda
Mathura Road,Gautampuri, sarita vihar,Delhi
South
DELHI
110076
India |
| Phone |
8280921028 |
| Fax |
|
| Email |
ayuarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Sah |
| Designation |
Pg Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no-406, Seminar room , Dept. of Kaumarabhritya and Bala Roga ,All india Institute of Ayurveda
Mathura Road,Gautampuri, sarita vihar,Delhi
South
DELHI
110076
India |
| Phone |
9717389679 |
| Fax |
|
| Email |
deepakkumar040496@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda
,Mathura Road ,Gautam puri,Sarita vihar,new Delhi India-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura road ,Gautampuri sarita vihar , Delhi-110076 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Deepak sah |
All India Institute of Ayurveda |
Room no 406
Department of
Kaumarbhritya
Academic Block All
India institute of
Ayurveda Gautampuri
Sarita vihar New Delhi
110076
South
DELHI
South
DELHI |
9717389679
deepakkumar040496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DIVISION OF TRANSLATIONAL RESEARCH AND BIOSTATISTICS All INDIA INSTITUTE OF AYURVEDA (AIIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Triphala ,Vacha and Musta Combination Tablet , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water ), Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: At least 45 minutes per day of moderate to vigorous activity such as running, cycling, swimming, or outdoor play
Limit non academic screen time to less than 1 hour per day.
Avoid screen use during meals and before bedtime.
Ensure 9 to 11 hours of sleep per night.
Maintain a fixed bedtime.
, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Prefer home cooked food, fruits, and boiled vegetables.
Do not skip breakfast.
, Apathya:Avoid sugary beverages and packaged foods. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 6 to 16 years of either sex diagnosed with obesity as per Extended Indian Academy of Paeditrics(IAP) BMI chart for boys and girls
Patients who are willing to participate and gave consent/Assent for this Study
|
|
| ExclusionCriteria |
| Details |
Patients age less than 6 and more than 16 years.
Taking medications from any system of medicines (allopathy or AYUSH)
Patients having systemic disorders which interfere with the present study.
Endocrinal disorders - hypothyroidism, Cushing syndrome and genetic disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in BMI by 0.5 unit in interventional group |
15days,30days,45days,60days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in anthropometric measurement (weight, Waist circumference , Skinfold thickness) and Ayurveda symptom scoring on Sthaulya |
15days,30days,45days,60days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized double blind placebo controlled prospective clinical trial designed to evaluate the efficacy of oral administration of Triphala Vacha and Musta combination tablet in the management of childhood obesity Sthaulya. The study will be conducted at the Department of Kaumarabhritya and Bala Roga All India Institute of Ayurveda New Delhi and will include 70 children aged 6 to 16 years diagnosed with obesity as per Extended Indian Academy of Pediatrics BMI charts. Participants will be randomly allocated into two groups of 35 each. The intervention group will receive Triphala Vacha and Musta combination tablets prepared in Ghana form administered orally in two divided doses before meals with lukewarm water for a duration of 60 days along with standard lifestyle recommendations while the control group will receive identical placebo tablets with the same schedule and lifestyle advice. Randomization will be computer generated and double blinding will be maintained for participants investigators and outcome assessors until completion of data analysis. The primary outcome measure is reduction in body mass index at the end of 60 days and secondary outcome measures include changes in body weight waist circumference skinfold thickness and Ayurvedic symptom score of Sthaulya. Safety will be monitored throughout the study and any adverse drug reactions will be documented and reported as per institutional pharmacovigilance guidelines. Written informed consent from parents or legal guardians and assent from children will be obtained prior to participation and the study will be initiated only after approval from the Institutional Ethics Committee and registration with the Clinical Trials Registry of India |