Healthy Volunteer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERSuvarnaprashana (Ayurvedic gold-based formulation)
A traditional Ayurvedic formulation containing purified gold, honey, and clarified butter (ghee), administered orally once daily for 30 days in a weight-based dose.
Sponsors
National Ayurveda Research and Training Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study uses a randomized, parallel assignment, open-label design. Forty healthy children aged 2-5 years are randomly allocated in a 1:1 ratio to either receive daily Suvarnaprashana (Ayurvedic gold-based formulation) for 30 days or to a standard-care control group. Randomization is stratified by baseline risk factors to ensure balanced groups. No blinding is applied due to the nature of the intervention and pilot feasibility focus.
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | 8 weeks | Count of participants who experienced at least one adverse event during the 8-week study period. |
| Change in ALT (IU/L) | 8 weeks | Mean difference in alanine aminotransferase (ALT) levels from baseline to week 8. |
| Change in AST (IU/L) | 8 weeks | Mean difference in aspartate aminotransferase (AST) levels from baseline to week 8. |
| Change in Bilirubin (mg/dL) | 8 weeks | Average change in serum bilirubin from baseline to week 8. |
| Change in Creatinine (mg/dL) | 8 weeks | Change in serum creatinine concentration from baseline to week 8. |
| Change in Hemoglobin (g/dL) | 8 weeks | Difference in hemoglobin concentration from baseline to week 8. |
| Change in WBC Count (10³/μL) | 8 weeks | Mean change in white blood cell count from baseline to week 8. |
| Change in Platelet Count (10³/μL) | 8 weeks | Mean change in platelet count from baseline to week 8. |
| Change in Serum Gold (μg/L) | 8 weeks | Difference in serum gold concentration from baseline to week 8. |
| Change in Urine Gold (μg/L) | 8 weeks | Difference in urine gold levels measured at baseline and week 8. |
| Change in IgA (mg/dL) | 8 weeks | Change in serum immunoglobulin A from baseline to week 8. |
| Change in IgM (mg/dL) | 8 weeks | Change in serum immunoglobulin M from baseline to week 8. |
| Change in IgG (mg/dL) | 8 weeks | Mean difference in serum immunoglobulin G from baseline to week 8. |
| Change in CD4+ T Cell Count (cells/μL) | 8 weeks | Change in CD4+ T lymphocyte count from baseline to week 8. |
| Change in CD8+ T Cell Count (cells/μL) | 8 weeks | Change in CD8+ T lymphocyte count from baseline to week 8. |
| Change in IL-4 (pg/mL) | 8 weeks | Difference in serum interleukin-4 levels from baseline to week 8. |
| Number of Infection Episodes per Participant | 8 weeks | Total number of infection episodes recorded per participant over the 8-week period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infection Episodes per Participant | 8 weeks | Total number of clinically confirmed infection episodes (e.g., respiratory, urinary tract, or other) per participant during the study, as recorded in standardized caregiver logs and assessed at site visits. |
| Duration of Infection Episodes (days) | 8 weeks | Average length in days of each infection episode per participant, measured from onset to resolution, as documented in caregiver logs and confirmed at site visits. |
| Severity of Infection Episodes (CTCAE Grade) | 8 weeks | Maximum severity grade of each infection episode per participant, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) during the 8-week study. |
| Number of Gastrointestinal Events per Participant | 8 weeks | Total number of gastrointestinal events per participant (e.g., diarrhea, vomiting, abdominal pain), recorded by caregivers and confirmed during clinic visits. |
| Duration of Gastrointestinal Events (days) | 8 weeks | Average number of days per gastrointestinal event per participant, as recorded in logs and confirmed at site visits. |
| Severity of Gastrointestinal Events (CTCAE Grade) | 8 weeks | Maximum severity grade for each gastrointestinal event per participant, graded according to CTCAE standards throughout the 8-week study period. |
Contacts
CONTACTAmit M Joshi, PhD
STUDY_CHAIRAmit Joshi, PhD
National Ayurveda Research and Training Center
Outcome results
None listed