Suvarnaprashana Pilot Study in Healthy Nepali Children Aged 2-5 Years

Introduction This prospective, single-site, non-randomized, open-label controlled pilot study aims to generate preliminary evidence on the short-term safety and potential immunomodulatory effects of Suvarnaprashana (SP), a traditional Ayurvedic intervention involving daily oral administration of a gold-based formulation (Suvarna Bhasma triturated with honey and ghee). Study Objectives Primary objectives focus on safety (monitoring adverse events, serious adverse events, and biochemical markers) and exploratory immunological changes (white blood cell differentials, immunoglobulins IgA/IgM/IgG, T-cell subsets CD4+/CD8+, cytokine IL-4, and infection incidence). Secondary objectives include monitoring gastrointestinal problems and overall infection episodes via caregiver logs and clinical assessments. Study Methods This prospective, open-label, controlled pilot study in Nepal enrolls healthy children. Children receive Suvarnaprashana or control (no intervention/standard care). Data collected via parental illness diaries, anthropometry, clinical examinations, and questionnaires at baseline and follow-ups assess safety (adverse events) and efficacy (immunity and morbidity). Analysis uses descriptive stats and basic comparisons. Expected Outcomes The pilot study anticipates demonstrating Suvarnaprashana as safe (low adverse events) with preliminary efficacy signals, including fewer illnesses and enhanced immunity in Nepali children versus controls. Results may justify larger trials and guide safe integration of this traditional practice into pediatric healthcare in Nepal.

Inclusion Criteria: * Healthy children aged 2-5 years * WHO Z-score between -2 and +2 standard deviations * Normal complete blood count (CBC), liver function test (LFT), and renal function test (RFT) * Written informed consent from parent or guardian * Ability to adhere to study protocol Exclusion Criteria: * Immunodeficiency (congenital or acquired) * Known hypersensitivity to gold, honey, or ghee * History of severe allergic reactions * Presence of any chronic illness or acute infection at screening