Safety and Preliminary Immunomodulatory Efficacy of Suvarnaprashana in Healthy Children Aged 2-5 Years: A Prospective, Open-Label, Randomized Controlled Pilot Study in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Suvarnaprashana (Ayurvedic gold-based formulation) (Other)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: 8 weeks
Count of participants who experienced at least one adverse event during the 8-week study period.
Change in ALT (IU/L)
时间窗: 8 weeks
Mean difference in alanine aminotransferase (ALT) levels from baseline to week 8.
Change in AST (IU/L)
时间窗: 8 weeks
Mean difference in aspartate aminotransferase (AST) levels from baseline to week 8.
Change in Bilirubin (mg/dL)
时间窗: 8 weeks
Average change in serum bilirubin from baseline to week 8.
Change in Creatinine (mg/dL)
时间窗: 8 weeks
Change in serum creatinine concentration from baseline to week 8.
Change in Hemoglobin (g/dL)
时间窗: 8 weeks
Difference in hemoglobin concentration from baseline to week 8.
Change in WBC Count (10³/μL)
时间窗: 8 weeks
Mean change in white blood cell count from baseline to week 8.
Change in Platelet Count (10³/μL)
时间窗: 8 weeks
Mean change in platelet count from baseline to week 8.
Change in Serum Gold (μg/L)
时间窗: 8 weeks
Difference in serum gold concentration from baseline to week 8.
Change in Urine Gold (μg/L)
时间窗: 8 weeks
Difference in urine gold levels measured at baseline and week 8.
Change in IgA (mg/dL)
时间窗: 8 weeks
Change in serum immunoglobulin A from baseline to week 8.
Change in IgM (mg/dL)
时间窗: 8 weeks
Change in serum immunoglobulin M from baseline to week 8.
Change in IgG (mg/dL)
时间窗: 8 weeks
Mean difference in serum immunoglobulin G from baseline to week 8.
Change in CD4+ T Cell Count (cells/μL)
时间窗: 8 weeks
Change in CD4+ T lymphocyte count from baseline to week 8.
Change in CD8+ T Cell Count (cells/μL)
时间窗: 8 weeks
Change in CD8+ T lymphocyte count from baseline to week 8.
Change in IL-4 (pg/mL)
时间窗: 8 weeks
Difference in serum interleukin-4 levels from baseline to week 8.
Number of Infection Episodes per Participant
时间窗: 8 weeks
Total number of infection episodes recorded per participant over the 8-week period.
次要结局
- 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)
- Severity of Gastrointestinal Events (CTCAE Grade)(8 weeks)
研究者
Santosh Kumar Thakur
Dr
National Ayurveda Research and Training Center