A clinical study to assess the efficacy & safety of Vasu Suvarnaprashan Drops in children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Changes in physical growth parameters
研究概览
简要总结
Suvarnaprashan drops, containing traditional Ayurvedic herbs like Shankhpushpi, Brahmi, Vacha, Honey, and Swarna Bhasma, have been historically used to promote cognitive function, immunity, growth, cardiorespiratory fitness, appetite, and sleep in children. Despite their historical usage, and demonstrated individual benefits in preliminary studies, modern scientific validation of these formulations in paediatric populations is limited, particularly in clinical safety and efficacy.
Given the critical physical and cognitive development in children aged 0 to 16 years, it is essential to provide evidence-based supplements that support optimal growth, development, and immune function. This open-label clinical trial will provide valuable data on the efficacy of Vasu Suvarnaprashan Drops in promoting growth, development, cardiorespiratory fitness, learning, cognition, concentration, and immune health while ensuring their safety for long-term use. This study aims to fill the current gap in evidence, offering insights that could inform both clinical practice and the broader acceptance of traditional Ayurvedic interventions in the pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children Aged 0-16 years inclusive (both gender) Participants will be equally distributed to age range from 0-5 years (Both inclusive) 5 plus to 10 years (Both inclusive) and 10 plus to 16 years (Both inclusive) that is 10 participants in each category.
- •2.Parents or guardians understand and are willing, able and likely to comply with all study procedures and restrictions.
排除标准
- •1.Participant has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product.
- •2.The participant has an ongoing illness requiring medical management.
- •3.The participant has a gastrointestinal infection and or acute diarrhea at the time of inclusion in the study.
- •4.The participant is currently taking medication that could affect the absorption or metabolism of the study product or the weight of the child.
- •5.The participant is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes congenital abnormalities of the respiratory tract congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma (As per history and or the medical records).
- •6.Any other condition that could interfere with the study outcomes as per the discretion of the investigator will be excluded from the study.
结局指标
主要结局
1.Changes in physical growth parameters
时间窗: screening, day 30, day 60, and day 90.
•Anthropometric parameters like height, body weight upper arm & chest circumference, and BMI.
时间窗: screening, day 30, day 60, and day 90.
次要结局
- 1.Effect on Immunological parameters like-(•Serum Immunoglobulin A, G levels)
研究者
Dr Kamlesh Satras
Sangvi Multispeciality Hospital Pvt. Ltd