Effect of balaposhaka granules in the management of failure to thrive in children - an open label, single arm, interventional clinical study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
Failure to thrive is a common pediatric growth disorder characterized by inadequate weight gain in children, leading to long-term physical and developmental consequences if untreated. Ayurveda emphasizes the role of proper nutrition, digestion, and strength-promoting formulation in ensuring healthy growth during childhood. Balaposhaka granules is an ayurvedic formulation traditionally made to enhance digestion, nourishment, and immunity in children. This study is an open label, single arm interventional clinical trial planned to evaluate the effect of balaposhaka granules in children aged 2 to 8 years diagnosed with failure to thrive based on WHO weight fpr age standards. A total of 40 participants will receive age appropriate dose of balaposhaka granules orally twice daily with milk for a duration of 4 weeks. The primary outcome measure is improvement in weight for age, while secondary outcomes include assessment of general health parameters such as appetite, activity level, sleep, bowel habits and overall well being. The study aims to assess the efficacy and safety of balaposhaka granules in the management of failure to thrive in children
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 2.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Children belonging to age group 2 to 8 years irrespective of religion, gender and socio-economic status.
- •2 Children diagnosed with Failure to thrive below 3rd and 5th percentile of weight-for- age according to WHO growth chart.
- •3 Children with normal cognitive milestone for age to ensure proper feeding and compliance.
- •Children who are medically stable with no acute illness at the time of enrollment.
Exclusion Criteria
- •1 Age below 2 years and above 8 years.
- •2 Children whose weight is above 5th percentile based on weight-for-age according to WHO growth chart.
- •3 Children having systemic, neurological, endocrinal, genetic disorders, congenital anomalies and anatomical defects.
Investigators
Dr Dipali Rakeshbhai Agrawal
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital