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

NCT07724561 | Not Yet Recruiting DMC

• 1 other identifier: 300 - 2026
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (6)

• Number of Infection Episodes per Participant

  8 weeks

• Duration of Infection Episodes (days)

  8 weeks

• Severity of Infection Episodes (CTCAE Grade)

  8 weeks

• Number of Gastrointestinal Events per Participant

  8 weeks

• Duration of Gastrointestinal Events (days)

  8 weeks

Study Arms (2)

Suvarnaprashana Oral Administration

EXPERIMENTAL

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)

Standard Care Only

NO INTERVENTION

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.

Interventions

Suvarnaprashana (Ayurvedic gold-based formulation) OTHER

A traditional Ayurvedic formulation containing purified gold, honey, and clarified butter (ghee), administered orally once daily for 30 days in a weight-based dose.

Suvarnaprashana Oral Administration

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Ayurveda Research and Training Center: lead

Study Officials

• Amit Joshi, PhD

  National Ayurveda Research and Training Center

  STUDY CHAIR

Central Study Contacts

Amit M Joshi, PhD

CONTACT

+977-9841091383; amitmanjoshi1981@gmail.com

Amit M Joshi, PhD

CONTACT

amitmanjoshi1981@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 27, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share