JMIR Publications

ABSTRACT

Background:

Malnutrition remains a significant public health challenge in India, with over 50% of children under five affected. Moderately malnourished children are particularly vulnerable to frequent infections due to compromised immune function. In Ayurveda scriptures, according to Acharya Kashyapa, Swarnprashan (processed gold administration) is recommended for children to improve immunity and overall health. While the immunomodulatory effects of Swarnprashan are documented in healthy children, its effect in malnourished populations remains unexplored.

Objective:

Objective of the study is to evaluate the effect of Swarnprashan on reducing the frequency of infections in children aged 5 to 10 years with moderate malnutrition, compared with a placebo control group, at 6 and 12 months

Methods:

This is a single-center, randomized, double-blind, placebo-controlled trial evaluating the immunomodulatory and nutritional effects of Swarnprashan in 160 moderately malnourished children aged 5-10 years, defined by WHO BMI-for-age standards. Participants will receive either Swarnprashan (3–4 mg Swarnabhasma with unequal quantities of honey and Ghrita) as anupana or a matching placebo of MCC, along with a uniform government-provided mid-day meal for six months.

Results:

The primary outcome is the frequency of infections in the two groups at 6 and 12 months. Secondary outcomes include changes in anthropometric measures, immunoglobulin levels, immune cell profiles, cytokine responses, neutrophil function (NETosis), and safety. Immune parameters will be assessed at baseline, 6 months, and 12 months.

Conclusions:

This trial is designed to evaluate the safety and efficacy of Swarnprashan in enhancing immune function and improving nutritional outcomes in children with moderate malnutrition. By integrating classical Ayurveda interventions with contemporary clinical research methodology, the study aims to generate evidence on the role of Swarnprashan in malnutrition and pediatric health. Findings from this trial may inform the integration of traditional formulations into public health nutrition programs, subject to further validation. Clinical Trial: The trial is registered prospectively with the Clinical Trials Registry of India (CTRI Registration No. CTRI/2023/04/051292) and approved by the Institutional Ethics Committee of SGPGIMS, Lucknow.