CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDANGADI CHURNA IN STHAULYA W.S.R. TO OVERWEIGHT IN CHILDREN
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To evaluate the role of Vidangadi Churna in Overweight children.
Study Overview
Brief Summary
The present clinical study is a open label randomized control clinical trial to evaluate the efficacy of Vidangadi Churna in overweight children. 30 patients of age group 10-15 years for present clinical study were selected from OPD and IPD of Kaumarabhritya, NIA, Jaipur. Selected patients were randomly divided in group A & group B with 15 patients in each group. Group A were given Vidangadi churna with dose of 1 gm twice a day with Madhu(Q.S). Group B is advised for modification in diet and lifestyle. Same pattern of diet and lifestyle modification followed in both groups which fulfill the caloric requirement of body and instruction chart were provided for diet and day to day activities. Total duration of the intervention was three month i.e. 2 month clinical trial with drug and lifestyle modification and one month post intervention follow up.The primary outcome measures is to evaluate the efficacy of Vidangadi Churna in overweight children. The secondary outcome is to restore normal physical activity and promote healthy lifestyle.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 10.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children of either sex aged between 10-15 years will be selected.
- •2.Children with Familial tendency of obesity.
- •3.Obesity due to sedentary lifestyle and dietary habits.
- •4.Children having BMI between 85th to 95th percentile of CDC growth charts 2000.
Exclusion Criteria
- •1.Children those are suffering from any systemic and endocrinal illness like DM, Hypothyroidism etc.
- •2.Obesity associated with chromosomal disorders/metabolic disorders.
- •3.Children those are already on treatment for obesity or other disorders.
- •4.Drug induced obesity.
Outcomes
Primary Outcomes
To evaluate the role of Vidangadi Churna in Overweight children.
Time Frame: 3 months
Secondary Outcomes
- To promote the physical and mental strength in overweight children with weight management.(3 months)