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

Detailed DescriptionThis is a prospective, single‐site, open‐label, randomized controlledpilot study designed to evaluate the safety and preliminary immunomodulatory efficacy ofSuvarnaprashana (SP) in healthy children aged 2‐5 years in Nepal. Suvarnaprashana is anAyurvedic formulation consisting of Good Manufacturing Practice (GMP)‐certified SuvarnaBhasma (gold ash) triturated with honey and ghee. While traditionally used to enhancechildhood immunity and development, robust clinical evidence is limited.Study Rationale:Traditional Ayurvedic texts suggest that Suvarnaprashana may support immune resilience,cognitive development, and overall health in children. Modern safety data for SuvarnaBhasma and its components, along with preliminary studies, support further investigationin a controlled setting. This pilot study aims to provide initial safety data and detectearly signals of immunomodulatory efficacy, which are essential before consideringlarger, definitive trials for integration into child health programs.Study Design andParticipants:The study will enroll 40 healthy children between 2 and 5 years of age, recruited fromthe Provincial Ayurveda Hospital in Bijauri, Dang, Nepal. Participants will be screenedfor eligibility using WHO growth charts, nutritional status, and laboratory criteria(normal CBC, liver, and renal function tests). Parental/guardian informed consent isrequired, and verbal assent will be sought from children aged 4 years orolder.Randomization and Allocation:Eligible children will be randomly assigned in a 1:1 ratio to either the interventiongroup (Suvarnaprashana plus standard care) or the control group (standard care only).Randomization will use a computer‐generated, permuted block method, with stratificationaccording to baseline risk factors (nutritional and perinatal status) to ensure groupbalance.Intervention:Children in the intervention group will receive a weight‐based daily oral dose ofSuvarnaprashana (1‐4 drops, each drop containing approximately 0.25 mg Suvarna Bhasma)for 30 days. The preparation is administered on an empty stomach each morning, ideallystarting near the Pushya Nakshatra period, with a ±7 day window for practicalfeasibility. The formulation's quality is verified by GMP certification and independentlaboratory testing (including ICP‐MS for heavy metals). Caregivers receive training indose administration and adherence is monitored through daily logs and weeklyfollow‐up.Children in both groups continue to receive all routine childhoodimmunizations, growth monitoring, and standard healthcare as per Nepal's nationalguidelines. No placebo is used in the control group.Assessments and Outcome Measures:Primary outcomes are safety (incidence and severity of adverse and serious adverseevents, changes in biochemical parameters, and serum/urine gold levels) and exploratorychanges in immunological markers (white blood cell differentials, immunoglobulinsIgA/IgM/IgG, T cell subsets CD4+/CD8+, cytokine IL‐4, and infection rates). Secondaryoutcomes include the number, type, duration, and severity of infection episodes andgastrointestinal symptoms, as captured by caregiver logs and clinical review. Baselineand end‐of‐study assessments involve laboratory tests and physical examinations. Weeklysafety monitoring and clinical assessments are performed throughout the interventionperiod.Data Collection and Monitoring:Data are captured using encrypted electronic case report forms (eCRFs) and structuredsymptom diaries maintained by caregivers. The Data Monitoring Committee, comprising apediatrician, biostatistician, and ethicist, oversees trial safety, with interim analysesand stopping rules for excess serious adverse events (>10%). Study procedures follow GoodClinical Practice (GCP), national ethical guidelines, and the Declaration ofHelsinki.Statistical Considerations:As a pilot study, the sample size (n=40) is designed for feasibility and initial datacollection, not for formal hypothesis testing. Analyses include descriptive statistics,intention‐to‐treat and per‐protocol comparisons, and exploratory use of regression modelsto investigate trends in safety and immunological parameters. Effect sizes and confidenceintervals will guide the design of future studies.Ethical Considerations and CommunityEngagement:Written informed consent is obtained from all parents/guardians, and verbal assent issought from children aged 4 years or older when appropriate. The study is approved by theInstitutional Research Committee (IRC) of NARTC and the Nepal Health Research Council(NHRC). A community advisory board with local representation provides guidance to ensurecultural sensitivity, and all participant data are kept strictlyconfidential.Significance:This study addresses the urgent need for evidence‐based evaluation of traditionalAyurvedic interventions in child health, aligned with World Health Organization (WHO)strategies for traditional medicine. Results will inform the feasibility, safety, andpotential immunological benefits of Suvarnaprashana in young children and provide afoundation for larger confirmatory trials and policy guidance in Nepal.