Efficacy of Triphaladi Ghana Vati, Udvartana and lifestyle modification in the management of Sthaulya (overweight) in children

Phase 3

Not yet recruiting

Conditions: Overweight. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA),

Registration Number: CTRI/2023/04/051858

Lead Sponsor: Institute of Teaching and Research in Ayurveda Jamnagar

Brief Summary: **Introduction:** Childhood overweight is growing in leaps and bounds, and becoming an epidemic health problem across the globe. It is pioneer to many lifestyle disorder. Thus, apart from malnutrition, overweight is a new rising concern in India. It is the new emerging epidemic that needs to be taken cared well in time. **Significance:** In the contemporary science there are only few treatment modalities for overweight like weight loss drugs (Hyroxycut, Meratrim and Orlistat), bariatric surgery (liposuction) and lifestyle interventions (diet and exercise). However, others except lifestyle intervention have known side effects. Because of limitations and inconsistency in tackling this problem, and the complications associated with contemporary health care system, this research topic has been selected. Ayurveda has mentioned detailed management of overweight under the heading of *Sthaulya* and *Santarpanotha Vyadhi*. Ayurveda treatment comprises *Shamana* as well as *Shodhana* therapy along with lifestyle modification. Various researches have also shown promising results with the help of these Ayurveda treatments in overweight children. **Aim and Objectives:** To evaluate the efficacy of *Triphaladi Ghana Vati*, *Udvartana* and lifestyle modification, in the management of *Sthaulya* (overweight) in children. **Materials and Methods:** 40 Children of either sex aged between 10-16 years with any 4 classical signs and symptoms of *Sthaulya* i.e., *Chala Sphika Udara Stana, Aalasya/Utsah hani, Kshudra shwasa/ Aayasen shwasa, Nidraadhikya, Swedaadhikya, Daurgandhya, Atipipasa, Atikshudha* will be enrolled in two groups. Group A: Trial group: *Triphaladi Ghana Vati* internal; *Udvartana* with *Yava Kulattha,* and life style modification. Group B: Placebo control group: Placebo drug and life style modification **Results and Discussion**: Data generated during the above study will be presented in a systemic manner and shall be analyzed statistically. **Follow up:** After completion of therapy, follow up will be done for 4 weeks (visit in every 15 days) to assess the status of patient, where the patient will be asked to report. **Adverse effects**: This proposal will be reviewed and approved by ITRA, Institutional Ethics Committee, which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse drug reactions if any observed will be reported to the Pharmacovigilance cell of ITRA.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Children aged between 10-16 years, irrespective of gender.
Individuals having BMI between 85th to 95th percentile of CDC growth charts.
Individuals with any 4 classical signs and symptoms of Sthaulya i.e., Chala Sphika Udara Stana, Aalasya/Utsah hani, Kshudra shwasa/ Aayasen shwasa, Nidraadhikya, Swedaadhikya, Daurgandhya, Atipipasa, Atikshudha.

Exclusion Criteria

Children who are known cases of any systemic, endocrinal illness like Diabetes Mellitus (Type-1), Thyroid disorders, Hypertension, Coronary Heart Disease (CHD), Asthma etc.
or known cases of any psychiatric or genetic disorders.
â€¢ Children who are known case of drug induced obesity and taking such drugs at present as well.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT)	Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT) \| âœ“ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid \| and in classical signs and symptoms of Sthaulya. (BT and AT)
and in classical signs and symptoms of Sthaulya. (BT and AT)	Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT) \| âœ“ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid \| and in classical signs and symptoms of Sthaulya. (BT and AT)
âœ“ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid	Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT) \| âœ“ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid \| and in classical signs and symptoms of Sthaulya. (BT and AT)

Secondary Outcome Measures

Name	Time	Method
Changes in anthropometric measurements (every 7 days), S. lipid	and in classical signs and symptoms of Sthaulya. (BT and AT)
Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT)	âœ“ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid

Trial Locations

Locations (1): PG Hospital Institute of Teaching and Research in Ayurveda
🇮🇳
Jamnagar, GUJARAT, India
PG Hospital Institute of Teaching and Research in Ayurveda
🇮🇳Jamnagar, GUJARAT, India
Anita Yadav
Principal investigator
7073914239
yadavanitaa6@gmail.com