Management of Childhood Obesity through Ayurved treatment protocol

Phase 3

Completed

• Conditions: Other obesity,

• Registration Number: CTRI/2020/12/029498
• Lead Sponsor: IPGT and RA

Brief Summary

In the presentresearch work, total 40 patients were enrolled. There were 2 groups (group Aand group B) and 20 patients were allocated to each group. Total treatmentprotocol was of 8weeks with 4weeks of follow up period, after the completion oftreatment protocol. Group A (trial group) patients received *Mustadi Ghana Vati* (500mg) according toweight (TDS) with warm water before food for 8weeks and 1week of *Udvartana* with *Yava-Kulattha Churna* for the initial 1week along with lifestylemodification (diet and exercise) for 8weeks. Group B (control group) patients wereadvised to follow lifestyle modification (diet and exercise) for 8weeks. Out of40 patients, total 38 (19 from each group) completed the treatment protocol andthere were 2 drop outs (1 from each group) due to loss to follow up. Through 8weeks of treatment, significantamount of weight reduction was observed, which was seen in more number ofpatients from group A than group B. In Group A - Extremely significant resultswere obtained in all subjective parameters, and in objective parameters likeweight, BMI, CC, AC, MTC, SFT, S. Triglycerides, S. VLDL, S. HDL and S.Adiponectin and very significant results were found in S. Cholesterol, WC andMUAC. In Group B – Extremely significant results were obtained in objectiveparameters like BMI, CC, AC, WC, and S. Adiponectin and very significantresults were obtained in all subjective parameters, and on objective parameterslike S. Triglycerides, S. HDL, S. VLDL, S. LDL, weight, MTC and SFT. Oncomparison between two groups, statistically significant difference was obtainedin *Nidraadhikya*, *Daurgandhya*, CC, MTC, SFT and S. Adiponectin.  Thus, after considering the above points, it wasconcluded that *Mustadi Ghana Vati* and*Udvartana* along with lifestylemodification are more effective than lifestyle modification alone in themanagement of *Sthaulya*.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study Completion: 2022-03-03
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Lipid Profile and serum adiponectin	On 0 day and 56th day

Trial Locations

Locations (1)

PG Hospital IPGT and RA Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

PG Hospital IPGT and RA Jamnagar

🇮🇳Jamnagar, GUJARAT, India

Dr Dipashree Gauns

Principal investigator

8275771830

dipashreegauns@gmail.com