Evaluating the Efficacy of Yoga Module and Aconitum heterophyllum Wall.Ex Royle (Atis) for the Management of Sthaulya (Overweight) with Comorbid Psychological Conditions: A Randomized Controlled Trial
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Km Mamta
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in Body Weight, BMI, Waist Circumference, and Waist-Hip Ratio from baseline week 0 to 12.
Overview
Brief Summary
This randomized controlled trial aims to evaluate the efficacy of a structured Yoga module and standardized processed Aconitum heterophyllum (Atis) root powder in the management of Sthaulya (overweight) with comorbid psychological conditions. A total of 120 participants aged 18 to 50 years with BMI 25 and above will be enrolled and randomly divided into three groups. Group A will receive Yoga intervention combined with standardized processed Aconitum heterophyllum root powder, Group B will receive Yoga intervention only, and Group C will serve as control with no intervention. The duration of the study will be 90 days. The primary outcomes will be changes in weight, body mass index, waist circumference, and waist hip ratio, along with psychological parameters measured by DASS 21, IWQOL, and EAT 26. Assessments will be carried out at baseline and after 90 days. The study is designed to provide scientific evidence on the role of Yoga and standardized Ayurvedic medicine in obesity management and associated psychological well being.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age-18 to 50 years With BMI greater than 24.5 Non yoga practioners Commitment to follow up intervention General diet recommendation.
Exclusion Criteria
- •Regular yoga practitioners Alcohol or substance abuse Pregnancy or lactation Severe psychiatric disorders.
Outcomes
Primary Outcomes
Change in Body Weight, BMI, Waist Circumference, and Waist-Hip Ratio from baseline week 0 to 12.
Time Frame: Baseline (week 0): Before starting the intervention | End of Study(week 12): After completion of the intervention.
Secondary Outcomes
- Psychological & quality of life parameters: Changes in Depression, Anxiety, & Stress measured by DASS-21, eating behavior patterns measured by EAT-26, & obesity-related quality of life measured by WHOQOL.(Baseline (Week 0): Before starting the intervention)
Investigators
Km Mamta
University of Patanjali