A Randomized Controlled Clinical Study to Evaluate Add-on Effect of Baladi Granules in the Management of Karshya Vyadhi (Mild to Moderate Undernutrition) in Children

Abstract

Background: Protein-energy malnutrition is a major contributor to childhood morbidity and mortality in India, with one-third of children under five undernourished. Ayurveda describes Karshya Vyadhi as undernutrition, managed with Brimhana and Balya therapies. Baladi Granules, a polyherbal, child-friendly formulation (Sida cordifolia, Withania somnifera, Asparagus racemosus, Glycyrrhiza glabra, Saccharum officinarum, with Zingiber officinale and Elettaria cardamomum), were developed to improve appetite, digestion, and growth. Materials and Methods: A randomized, controlled, open-label clinical trial was conducted on 122 children (1–12 years) with mild-to-moderate undernutrition (weight-for-age 60–80%, IAP classification) at Dr. D. Y. Patil Ayurved Hospital, Pimpri, Pune. Participants were randomized into Group A (Baladi Granules + standard undernutrition diet) and Group B (diet alone). Intervention lasted 30 days. Primary outcome was change in weight-for-age and body weight; secondary outcomes included MUAC, height-for-age, muscle wasting, hunger, general appearance, weakness, adherence, and safety. Results: Out of 122 enrolled, 116 completed the trial. Group A demonstrated significantly greater mean weight gain (0.48 kg vs. 0.26 kg), MUAC improvement (0.43 cm vs. 0.30 cm), and more linear growth (0.64 cm vs. 0.41 cm) compared to controls. Subjective parameters (hunger, general appearance, weakness, muscle wasting) also improved more in Group A, with 53.45% showing marked improvement versus 20.69% in controls. No adverse events were reported. Conclusions: Baladi Granules, as an adjunct to diet, are safe, palatable, and effective in improving anthropometric and clinical outcomes in children with undernutrition. Further large-scale studies are warranted.