| CTRI Number |
CTRI/2025/03/083078 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE NUMBER OF CHILDREN AFFECTED WITH OBESITY AND EFFECT OF AYURVEDIC COMPOUND AMRITADI
GUGGULU AND RUKSHA UDVARTANA REDUCED THE WEIGHT IN CHILDREN.ALSO TO STUDY THE VARIOUS FACTORS RESPONSIBLE FOR THE WEIGHT GAIN IN CHILDREN. |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Amritadi Guggulu and Ruksha Udvartana in the Management of Sthaulya W.S.R. Obesity in children. |
| 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 Ashok Mundotiya |
| Designation |
pg scholar |
| Affiliation |
madan mohan malviya govt collage |
| Address |
PG DEPARTMENT OF KAUMARBHRTYA
madan mohan malviya govt ayurveda collage radaji circle ambamata udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
08824119924 |
| Fax |
|
| Email |
ashokmundotiya91926@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Mundotiya |
| Designation |
pg scholar |
| Affiliation |
madan mohan malviya govt collage |
| Address |
PG DEPARTMENT OF KAUMARBHRTYA
madan mohan malviya govt ayurveda collage radaji circle ambamata udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
08824119924 |
| Fax |
|
| Email |
ashokmundotiya91926@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
prof ram kumar |
| Designation |
professor & HOD |
| Affiliation |
madan mohan malviya govt ayurveda collage radaji circle ambamata udaipur |
| Address |
PG DEPARTMENT OF KAUMARBHRTYA
madan mohan malviya govt ayurveda collage radaji circle ambamata udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005857838 |
| Fax |
|
| Email |
drbhamuramkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt Ayurveda Collage Udaipur, Rajasthan
Pin Code - 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt Ayurveda Collage Udaipur |
| Address |
PG Department of Kaumarbhritya,
Madan Mohan Malviya Govt Ayurveda Collage Udaipur, Rajasthan
Pin Code- 313001
|
| 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 Ashok mundotiya |
madan mohan malviya govt ayurveda college udaipur |
opd no 3 govt ayurveda hospital moti choatta udaipur &
opd no 4 college parisar hospital radaji circle ambamata udaipur
Udaipur
RAJASTHAN |
08824119924
ashokmundotiya91926@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: AMRITADI GUGGULU , Reference: vangsena , Route: Oral, Dosage Form: Guggulu , Dose: 7(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: honey ), Additional Information: amritadi guggulu with ruksh udvartana | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadi Guggulu, Reference: vangsen , Route: Oral, Dosage Form: Guggulu , Dose: 7(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: honey ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children whose parents are willing to give consent for clinical trial.
2.Children aged group from 8-16 years having clinical signs & symptoms of childhood obesity described in Ayurveda classics and modern literature.
3.Children with BMI 86th percentile - 94th percentile and above 95th percentile.
4.Childrens of both sexes will be considered in the study.
5.Children shows cardinal feature of childhood obesity will be selected.
|
|
| ExclusionCriteria |
| Details |
1. Children aged below 7 years and above 16 years of age.
2. Children receiving drugs like steroids and anti- depressants drugs.
3. Childhood obesity due to endocrinal disorders like Cushing syndrome, hypothyroidism etc.
4. Children with BMI below 85th percentile is not considered.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in investigation and subjective parameter |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in the subjective parameters |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/04/2025 |
| 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="0"
Months="10"
Days="10" |
|
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 focuses on a pharmacognostical and clinical evaluation of Amritadi Guggulu and Ruksha Udvartana in managing Sthaulya (obesity) in children. The study will consist of two groups:
Group A: Participants will receive Amritadi Guggulu at a dosage of 14 mg/kg/day and Ruksha Udvartana (dry powder) applied for 20 minutes daily, either in the morning or evening on an empty stomach.
Group B: Participants will receive Amritadi Guggulu at a dosage of 14 mg/kg/day without the Ruksha Udvartana.
The trial will be conducted over a period of 8 weeks. |