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

Detailed DescriptionThis is a prospective, single-site, open-label, randomized controlled pilot study designed to evaluate the safety and preliminary immunomodulatory efficacy of Suvarnaprashana (SP) in healthy children aged 2-5 years in Nepal. Suvarnaprashana is an Ayurvedic formulation consisting of Good Manufacturing Practice (GMP)-certified Suvarna Bhasma (gold ash) triturated with honey and ghee. While traditionally used to enhance childhood 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 Suvarna Bhasma and its components, along with preliminary studies, support further investigation in a controlled setting. This pilot study aims to provide initial safety data and detect early signals of immunomodulatory efficacy, which are essential before considering larger, definitive trials for integration into child health programs.Study Design and Participants:

The study will enroll 40 healthy children between 2 and 5 years of age, recruited from the Provincial Ayurveda Hospital in Bijauri, Dang, Nepal. Participants will be screened for eligibility using WHO growth charts, nutritional status, and laboratory criteria (normal CBC, liver, and renal function tests). Parental/guardian informed consent is required, and verbal assent will be sought from children aged 4 years or older.Randomization and Allocation:

Eligible children will be randomly assigned in a 1:1 ratio to either the intervention group (Suvarnaprashana plus standard care) or the control group (standard care only). Randomization will use a computer-generated, permuted block method, with stratification according to baseline risk factors (nutritional and perinatal status) to ensure group balance.Intervention:

Children in the intervention group will receive a weight-based daily oral dose of Suvarnaprashana (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, ideally starting near the Pushya Nakshatra period, with a ±7 day window for practical feasibility. The formulation's quality is verified by GMP certification and independent laboratory testing (including ICP-MS for heavy metals). Caregivers receive training in dose administration and adherence is monitored through daily logs and weekly follow-up.Children in both groups continue to receive all routine childhood immunizations, growth monitoring, and standard healthcare as per Nepal's national guidelines. No placebo is used in the control group.Assessments and Outcome Measures:

Primary outcomes are safety (incidence and severity of adverse and serious adverse events, changes in biochemical parameters, and serum/urine gold levels) and exploratory changes in immunological markers (white blood cell differentials, immunoglobulins IgA/IgM/IgG, T cell subsets CD4+/CD8+, cytokine IL-4, and infection rates). Secondary outcomes include the number, type, duration, and severity of infection episodes and gastrointestinal symptoms, as captured by caregiver logs and clinical review. Baseline and end-of-study assessments involve laboratory tests and physical examinations. Weekly safety monitoring and clinical assessments are performed throughout the intervention period.Data Collection and Monitoring:

Data are captured using encrypted electronic case report forms (eCRFs) and structured symptom diaries maintained by caregivers. The Data Monitoring Committee, comprising a pediatrician, biostatistician, and ethicist, oversees trial safety, with interim analyses and stopping rules for excess serious adverse events (\>10%). Study procedures follow Good Clinical Practice (GCP), national ethical guidelines, and the Declaration of Helsinki.Statistical Considerations:

As a pilot study, the sample size (n=40) is designed for feasibility and initial data collection, not for formal hypothesis testing. Analyses include descriptive statistics, intention-to-treat and per-protocol comparisons, and exploratory use of regression models to investigate trends in safety and immunological parameters. Effect sizes and confidence intervals will guide the design of future studies.Ethical Considerations and Community Engagement:

Written informed consent is obtained from all parents/guardians, and verbal assent is sought from children aged 4 years or older when appropriate. The study is approved by the Institutional Research Committee (IRC) of NARTC and the Nepal Health Research Council (NHRC). A community advisory board with local representation provides guidance to ensure cultural sensitivity, and all participant data are kept strictly confidential.Significance:

This study addresses the urgent need for evidence-based evaluation of traditional Ayurvedic interventions in child health, aligned with World Health Organization (WHO) strategies for traditional medicine. Results will inform the feasibility, safety, and potential immunological benefits of Suvarnaprashana in young children and provide a foundation for larger confirmatory trials and policy guidance in Nepal.

• Number of Infection Episodes per Participant [Срок оценки: 8 weeks]
• Duration of Infection Episodes (days) [Срок оценки: 8 weeks]
• Severity of Infection Episodes (CTCAE Grade) [Срок оценки: 8 weeks]
• Number of Gastrointestinal Events per Participant [Срок оценки: 8 weeks]
• Duration of Gastrointestinal Events (days) [Срок оценки: 8 weeks]
• Severity of Gastrointestinal Events (CTCAE Grade) [Срок оценки: 8 weeks]