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

Safety and Preliminary Immunomodulatory Efficacy of Suvarnaprashana in Healthy Children Aged 2-5 Years: A Prospective, Open-Label, Randomized Controlled Pilot Study in Nepal

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Immune Function; Healthy Children; Immunomodulation
• Intervention / Treatment: Other: Suvarnaprashana (Ayurvedic gold-based formulation)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit M Joshi, PhD; Phone Number: +977-9841091383; Email: amitmanjoshi1981@gmail.com
• Study Contact Backup: Name: Amit M Joshi, PhD; Email: amitmanjoshi1981@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suvarnaprashana Oral Administration; Children aged 2-5 years in this arm receive daily oral Suvarnaprashana for 30 days. The formulation consists of GMP-certified Suvarna Bhasma (gold), honey, and ghee, administered in a weight-based dose (1-4 drops) each morning on an empty stomach. All participants also receive standard care including immunizations and health monitoring as per national guidelines. Adherence is monitored with caregiver logs and weekly clinical assessments.	Other: Suvarnaprashana (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.
No Intervention: Standard Care Only; Children aged 2-5 years in this arm receive only routine childhood healthcare as per Nepal's national guidelines, including immunizations, growth monitoring, and illness management. No Suvarnaprashana or other investigational product is administered. Health outcomes and adverse events are monitored similarly to the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	Count of participants who experienced at least one adverse event during the 8-week study period.	8 weeks
Change in ALT (IU/L)	Mean difference in alanine aminotransferase (ALT) levels from baseline to week 8.	8 weeks
Change in AST (IU/L)	Mean difference in aspartate aminotransferase (AST) levels from baseline to week 8.	8 weeks
Change in Bilirubin (mg/dL)	Average change in serum bilirubin from baseline to week 8.	8 weeks
Change in Creatinine (mg/dL)	Change in serum creatinine concentration from baseline to week 8.	8 weeks
Change in Hemoglobin (g/dL)	Difference in hemoglobin concentration from baseline to week 8.	8 weeks
Change in WBC Count (10³/μL)	Mean change in white blood cell count from baseline to week 8.	8 weeks
Change in Platelet Count (10³/μL)	Mean change in platelet count from baseline to week 8.	8 weeks
Change in Serum Gold (μg/L)	Difference in serum gold concentration from baseline to week 8.	8 weeks
Change in Urine Gold (μg/L)	Difference in urine gold levels measured at baseline and week 8.	8 weeks
Change in IgA (mg/dL)	Change in serum immunoglobulin A from baseline to week 8.	8 weeks
Change in IgM (mg/dL)	Change in serum immunoglobulin M from baseline to week 8.	8 weeks
Change in IgG (mg/dL)	Mean difference in serum immunoglobulin G from baseline to week 8.	8 weeks
Change in CD4+ T Cell Count (cells/μL)	Change in CD4+ T lymphocyte count from baseline to week 8.	8 weeks
Change in CD8+ T Cell Count (cells/μL)	Change in CD8+ T lymphocyte count from baseline to week 8.	8 weeks
Change in IL-4 (pg/mL)	Difference in serum interleukin-4 levels from baseline to week 8.	8 weeks
Number of Infection Episodes per Participant	Total number of infection episodes recorded per participant over the 8-week period.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Infection Episodes per Participant	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.	8 weeks
Duration of Infection Episodes (days)	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.	8 weeks
Severity of Infection Episodes (CTCAE Grade)	Maximum severity grade of each infection episode per participant, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) during the 8-week study.	8 weeks
Number of Gastrointestinal Events per Participant	Total number of gastrointestinal events per participant (e.g., diarrhea, vomiting, abdominal pain), recorded by caregivers and confirmed during clinic visits.	8 weeks
Duration of Gastrointestinal Events (days)	Average number of days per gastrointestinal event per participant, as recorded in logs and confirmed at site visits.	8 weeks
Severity of Gastrointestinal Events (CTCAE Grade)	Maximum severity grade for each gastrointestinal event per participant, graded according to CTCAE standards throughout the 8-week study period.	8 weeks

Collaborators and Investigators

• Sponsor: National Ayurveda Research and Training Center
• Investigators: Study Chair: Amit Joshi, PhD, National Ayurveda Research and Training Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 27, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 300 - 2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to concerns about participant privacy, local regulatory requirements, and the pilot nature of the study. Data sharing may be reconsidered in future, larger studies if required by regulatory agencies and with appropriate safeguards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No