AN OPEN LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECT OF PEDESHEILD SYRUP IN PROMOTING GROWTH PARAMETERS IN MODERATELY UNDERWEIGHT CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the effect of Pedesheild Syrup along with ICDS standard diet on physical growth parameters such as weight and height and BMI in moderately underweight children
研究概览
简要总结
This open label randomized clinical trial evaluates the efficacy and safety of Pedesheild Syrup a polyherbal Ayurvedic formulation in improving growth parameters of moderately underweight children aged 3 to 5 years along with the ICDS standard diet Based on Ayurvedic principles of Rasayana Deepana Pachana Agni enhancement Dhatu nourishment and Ojas support 120 children will be treated for 90 days with assessment of weight height BMI and other anthropometric measures aiming to establish Pedesheild Syrup as a safe palatable and effective integrative therapy for healthy growth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects within age group 3 to 5 years will be included in the study irrespective of sex, caste and religion Subjects with the weight from less than minus 2 SD for the expected weight for age Parents or Guardian willing to give informed written consent to participate in the study.
排除标准
- •Patient associated with Severe malnutrition.
- •K or co or o Congenital Diseases, Inborn Errors of Metabolism and any other systemic disorders.
- •Severely underweight children.
- •(less than 3 SD as per WHO Child Growth Standard 2006).
结局指标
主要结局
To assess the effect of Pedesheild Syrup along with ICDS standard diet on physical growth parameters such as weight and height and BMI in moderately underweight children
时间窗: 30 days 60 days 90 days
次要结局
- To assess the safety, palatability, and compliance of the Pedesheild Syrup along with ICDS standard diet in moderately underweight pediatric population(30 days 60 days 90 days)
研究者
Rehan mujeeb khan
Parul institude of ayurved , Parul university