Ayush Bala Rakshak Leham for Moderate Malnutrition in Children Aged 3 to 5 Years: Protocol for a Pilot Randomized Controlled Trial.

Abstract

Malnutrition, a leading cause of mortality and morbidity in children aged <5 years, requires early detection and intervention. In Ayurveda, "Kumarasosha" closely corresponds to childhood malnutrition, with its pathophysiology and treatment principles offering a more precise and effective approach to management. This study is designed to evaluate the efficacy and safety of Ayush Bala Rakshak (BR) Leham in moderately malnourished children aged 3 to 5 years. This is a multicenter, open-label, randomized controlled, 2-group pilot study designed to enroll 200 moderately malnourished children, 100 from each participating study center of the Central Council for Research in Ayurvedic Sciences. The children will be screened for moderate malnutrition using the World Health Organization weight-for-age Z score through the AnthroCal app developed by the All India Institute of Medical Sciences, New Delhi. After obtaining consent from parents, the participants will be randomized and allocated to 2 groups. The study group will receive Aravindasava, 5 mL twice daily after food for 4 weeks, followed by Ayush BR Leham, a nutritional supplement, 5 g twice daily before food from weeks 5 to 12. The control group will receive Aravindasava for 4 weeks and thereafter receive no intervention for 8 weeks. Both groups will be advised to follow a home-prepared diet during the study period. A follow-up assessment will be conducted after 4 weeks. The primary outcome is a change of ≥0.5 in the World Health Organization weight-for-age Z scores, and the secondary outcomes are changes in anthropometric measurements, the frequency of illnesses assessed using a predesigned table, and safety parameters assessed using biochemical measures. The study received funding in March 2023. Participant enrolment commenced on December 16, 2023 and has been completed. After data analysis, the study findings are expected to be submitted for publication in December 2026. The study will investigate the efficacy and safety of Ayush BR Leham in moderately malnourished children aged 3 to 5 years. If the intervention is found to be effective, the findings may help incorporate Ayurvedic guidelines into standard treatment protocols for children with moderate malnutrition. Clinical Trials Registry of India CTRI/2023/07/055188; https://tinyurl.com/3arpbecm. DERR1-10.2196/93718.