Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 18, 2026
Date Accepted: May 27, 2026
Ayush-BR Leham in 3–5 Year Old Children with Moderate Malnutrition: Protocol for an Exploratory Pilot RCT
ABSTRACT
Background:
Malnutrition, a leading cause of mortality and morbidity in the under-five age group, 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.
Objective:
This study is designed to evaluate the efficacy and safety of Ayush-BR leham, in moderately malnourished children aged 3-5 years.
Methods:
It is a multicentric, open, randomized controlled, two-group pilot study, designed for enrolling 200 moderately malnourished children - 100 from each study centre of CCRAS. The children will be screened for moderate malnutrition using the WHO Weight for Age Z score through the Anthrocal App developed by the All India Institute of Medical Sciences, New Delhi. After obtaining consent from the parent, the participants will be randomized and allocated to two groups. The study group will receive Aravindasava, 5 ml twice daily after food for 4 weeks followed by Ayush BR leha, a coded formulation developed by CCRAS, 5 gm twice daily before food from 5th to 12th week. The control group will receive Aravindasava for 4 weeks, thereafter without any intervention for 8 weeks. Both groups are advised a homely diet during the study period. A follow-up assessment is done after 4 weeks. The primary outcome is a change in WHO Weight-for-Age Z scores of 0.5 or more, and secondary outcomes are changes in anthropometric measurements, changes in the frequency of illnesses assessed using a pre-designed table, and assessment of safety parameters using biochemical parameters.
Results:
The study is ongoing at two CCRAS centers. After completion, the study will be subjected to statistical analysis. The results are expected to be published in the year 2026.
Conclusions:
The study will investigate the efficacy and safety of Ayush BR leham in moderately malnourished children aged 3-5 years. The study, if found effective, may help incorporate Ayurvedic guidelines into the standard protocol for treating children with moderate malnutrition. Clinical Trial: Clinical Trials Registry of India [CTRI/2023/07/055188]; https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=86623&EncHid=38686.66776&modid=1&compid=19
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