A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Non-comparator study to assess the efficacy and safety of AshwaVita Nutrition Powder in participants (children age between 1 to 15 years) with uncomplicated severe and moderate acute malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Assessment of change in Mid Upper Arm Circumference from baseline value
研究概览
简要总结
This study is a randomized, multiple-dose, two-arm, placebo-controlled, double blind, parallel design evaluating efficacy and safety of AshwaVita Nutrition Powder in 150 children with uncomplicated severe and moderate acute malnutrition for 12 weeks in India.
The primary outcome measures will be change in Mid Upper Arm Circumference, change in weight-for-height Z score & change in weight from baseline weight at week 12.
Overall, aim of the propose research is to validate efficacy & safety of AshwaVita Nutrition Powder in acute malnutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Child with Moderate or Severe Acute Malnutrition Child parent/legal representative willing to give a voluntary written informed consent and agree to come for regular follow up Child assent (verbal oral or written as applicable).
排除标准
- •Child having other acute and chronic systemic illnesses or requiring emergency management Child has a known hypersensitivity to any of the study drugs or excipients Child with developmental disorders like cerebral palsy or intellectual disability Child with an inborn error of metabolism, congenital abnormalities Child with a known history or present condition of allergic response to milk or any other ingredient of the formulation Child with neurobehavioral disorders like ADHD autism.
结局指标
主要结局
Assessment of change in Mid Upper Arm Circumference from baseline value
时间窗: Week 12
Assessment of change in weight-for-height Z score (as applicable)
时间窗: Week 12
Assessment of change in weight from baseline weight
时间窗: Week 12
次要结局
- Assessment of change in BMI from baseline value(Assessment of change in weight-for-age Z score (as applicable) at week 12)
研究者
Dr Mahesh Rathod
Sardar Children Hospital