| CTRI Number |
CTRI/2020/12/029498 [Registered on: 02/12/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Childhood Obesity through Ayurved treatment protocol |
|
Scientific Title of Study
|
Efficacy of Mustadi Ghana Vati and Udvartana in the Management of Sthaulya w s r to Childhood Obesity An Open Labeled Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DIPASHREE GAUNS |
| Designation |
MD Scholar |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Kaumarbhritya IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
Gujarat
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
8275771830 |
| Fax |
|
| Email |
dipashreegauns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anup B Thakar |
| Designation |
HOD and Director |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Director Office 1st Floor Institute building IPGT and RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar M Bhinde |
| Designation |
Assistant Professor |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Department of Kaumarbhritya 5th Floor Institute building IPGT and RA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9662512158 |
| Fax |
|
| Email |
sgrbhinde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opposite Reliance Smart Department of Kaumarbhritya IPGT and RA GAU Jamnagar |
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
IPGT and RA GAU Jamnagar Gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dipashree Gauns |
PG Hospital IPGT and RA Jamnagar |
OPD No 15 Department of Kaumarbhritya IPGT and RA Jamnagar
Jamnagar
GUJARAT |
8275771830
dipashreegauns@gmail.com |
|
|
Details of Ethics Committee
|
| 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: E668||Other obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mustadi Ghana Vati and
Udvartana and
Diet and Exercise Regimen |
Udvartana with Yava Kulattha churna dry powder massage for 20mins for initial 1 week along with Mustadi Ghana Vati 3times per day and lifestyle modification viz Diet and Exercise followed by Mustadi Ghana Vati 3times per day only for the rest of the 7weeks along with Lifestyle modification viz Diet and Excercise |
| Comparator Agent |
Only Diet and Exercise |
Only Lifestyle Modification viz Diet and Exercise |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having BMI more than 95th percentile of CDC growth Charts
Symptoms of Sthaulya viz Chala Sphik udara sthana Aalasya Utsah haani Kshudra shwasa Nidra adhikya Sweda adhikya Daurgandhya Daurbalya Atipipasa Atikshuda
Children on oral medication for obesity will be included into the study after a wash out period of 2weeks |
|
| ExclusionCriteria |
| Details |
Children aged less than 6yrs and more than 16yrs
Who are known case of any systemic endocrinal illnesses like DM Thyroid disorders HTN CHD Asthma etc or known case of any psychiatric or genetic disorders
Who are known case of drug induced obesity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predefined assessment parameters of classical sthaulya symptoms like Chala sphika udara sthana Aalasya Utsah haani Kshudra Shwasa Nidra adhikya Sweda adhikya Daurgandhya Daurbalya Atipipasa Atikshudha |
on 0 day and 56th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lipid Profile and serum adiponectin |
On 0 day and 56th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/01/2021 |
| Date of Study Completion (India) |
03/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In the present
research work, total 40 patients were enrolled. There were 2 groups (group A
and group B) and 20 patients were allocated to each group. Total treatment
protocol was of 8weeks with 4weeks of follow up period, after the completion of
treatment protocol. Group A (trial group) patients received Mustadi Ghana Vati (500mg) according to
weight (TDS) with warm water before food for 8weeks and 1week of Udvartana with Yava-Kulattha Churna for the initial 1week along with lifestyle
modification (diet and exercise) for 8weeks. Group B (control group) patients were
advised to follow lifestyle modification (diet and exercise) for 8weeks. Out of
40 patients, total 38 (19 from each group) completed the treatment protocol and
there were 2 drop outs (1 from each group) due to loss to follow up. Through 8weeks of treatment, significant
amount of weight reduction was observed, which was seen in more number of
patients from group A than group B. In Group A - Extremely significant results
were obtained in all subjective parameters, and in objective parameters like
weight, BMI, CC, AC, MTC, SFT, S. Triglycerides, S. VLDL, S. HDL and S.
Adiponectin and very significant results were found in S. Cholesterol, WC and
MUAC. In Group B – Extremely significant results were obtained in objective
parameters like BMI, CC, AC, WC, and S. Adiponectin and very significant
results were obtained in all subjective parameters, and on objective parameters
like S. Triglycerides, S. HDL, S. VLDL, S. LDL, weight, MTC and SFT. On
comparison between two groups, statistically significant difference was obtained
in Nidraadhikya, Daurgandhya, CC, MTC, SFT and S. Adiponectin. Thus, after considering the above points, it was
concluded that Mustadi Ghana Vati and
Udvartana along with lifestyle
modification are more effective than lifestyle modification alone in the
management of Sthaulya.
|