A Clinical Trial to study the effect of an Ayurvedic drug, Thriphalaguduchyadi vati, in children with Obesity

Phase 2

Completed

• Conditions: Obesity

• Registration Number: CTRI/2011/10/002081
• Lead Sponsor: Department of Kaumarabhritya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-06
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• •Children with Body Mass Index ≥ 95th percentile for that age and sex.
• •Children with signs and symptoms of Sthaulya (obesity) due to exogenous causes.

Exclusion Criteria

• •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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Body Mass Index	3 months

Secondary Outcome Measures

Name	Time	Method
Reduction in Bio Marker and Risk factors	Apolipoprotein B

Trial Locations

Locations (1)

P.G. Ayurveda Hospital, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

P.G. Ayurveda Hospital, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar

🇮🇳Jamnagar, GUJARAT, India

Biju KR

Principal investigator

9429807839

drbijukr@yahoo.co.in