| CTRI Number |
CTRI/2011/10/002081 [Registered on: 20/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
14/10/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of an Ayurvedic drug, Thriphalaguduchyadi vati, in children with Obesity |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFICACY OF TRIPHALA GUDUCHYADI VATI IN THE MANAGEMENT OF STHAULYA (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 |
Biju KR |
| Designation |
Ph.D.Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Kaumarabhritya
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurveda University
Jamnagar
Gujarat Ayurveda University
Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9429807839 |
| Fax |
|
| Email |
drbijukr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalpana S Patel |
| Designation |
Reader |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Head Of the Department
Department of Kaumarabhritya
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurveda University
Jamnagar
Gujarat Ayurveda University
Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana S Patel |
| Designation |
Reader |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Head Of the Department
Department of Kaumarabhritya
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurveda University
Jamnagar
Gujarat Ayurveda University
Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat ayurveda University, Jamnagar. |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarabhritya |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat ayurveda University, Jamnagar. |
| 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 |
| Biju KR |
P.G. Ayurveda Hospital, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar |
Room No.15A
Out Patient Block Department of Kaumarabhritya
P.G.Ayurveda Hospital,Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurveda University, Jamnagar 361008
Jamnagar
GUJARAT |
9429807839
drbijukr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurveda University, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo control- Wheat flour tablet |
Wheat flour tablet: 5-8 tab (as per age) tds for three months, along with water (half or one glass)mixed with honey(one spoon). |
| Intervention |
Triphalaguduchyadi vati, low-fat diet, exercise
|
Triphalaguduchyadi vati:
5-8 tab (as per age) tds for three months, along with water (half or one glass) mixed with honey(one spoon).
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
•Children with Body Mass Index ≥ 95th percentile for that age and sex.
•Children with signs and symptoms of Sthaulya (obesity) due to exogenous causes.
|
|
| ExclusionCriteria |
| Details |
•Children with obesity due to endocrinal causes, genetic causes, psychiatric causes will be excluded from the study on clinical basis.
•Children suffering from severe systemic illnesses like Hypertension, Diabetes Mellitus etc will also be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Body Mass Index
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Bio Marker and Risk factors
Apolipoprotein B
LDL
Triglycerides
HDL (elevation)
Blood Pressure
Pasma Sugar level |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, placebo controlled, single blind, parallel group trial for the efficacy of Triphalaguduchyadi vati 5-8 (as per age) tab (500 mg) tds with honey for a period of 3 months in the management of Sthaulya (Obesity) in 100 Children of 10-16 yrs old. Triphalaguduchyadi vati is a herbal preparation mentioned in Ashtanga Samgraha, one of the main classics of Ayurveda, for Obesity. Scientific names of the ingredients are Terminalia chebula (Hareetaki), Terminalia Bellerica (Vibheetaki), Emblica officinalis (Aamalaki), Tinospora cordifolia (Guduchi) and Cyperus rotundus (Musta). The primary outcome measures will be reduction in Body Mass Index after 3 months of medication.
|