A Two Arm, Randomized, Open Labeled, Prospective, Clinical Study to Evaluate efficacy and safety of Dabur Chyawanprash in Health & Immunity related Parameters in Healthy children – A School Based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Assessment of immunity through episodes severity and duration of illness (infections or allergies) in the two study groups based on subject diary
研究概览
简要总结
This study is a Two Arm, Randomized, Open Labeled, Prospective, Clinical Study to Evaluate efficacy and safety of Dabur Chyawanprash in Health & Immunity related Parameters in Healthy children. The study will be multicentric, and healthy subjects in the age group of 05-12 years will be randomized to either of the two groups i.e. Group A - Dabur Chyawanprash followed by milk twice daily and Group B - only milk twice daily in 1:1 ratio.The glass of milk may be between 100-200 ml. Treatment period will be of 180 days with total visit of 8 visits including screening and randomization. Expected no of completers for the study is planned to be 600 subjects . The study would include various assessment parameters to assess the quality of life (QOL), number of episodes, severity and duration of illness during the study period, level of Energy, overall health status, level of physical fitness, level of stamina and physical strength and assessment of safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Healthy children of either sex of 5-12 years (both inclusive) 2 Ready to provide informed consent from parent/ legally accepted guardian 3 No significant medical or surgical disease/s at the time of screening 4 No history of allergic conditions to Chyawanprash like products/any ingredients of the Chyawanprash and are not averse to consuming Chyawanprash for the study period 5 Willing to come for the follow up visits for evaluation.
排除标准
- •1 Presence of any clinically significant medical or surgical condition requiring long term treatment 2 Subjects participating/participated in another clinical study within 3 months before recruitment 3 Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation 4 Immunologically compromised children.
结局指标
主要结局
Assessment of immunity through episodes severity and duration of illness (infections or allergies) in the two study groups based on subject diary
时间窗: 180 days (6 months)
次要结局
- Assessment will done in two study groups - immunity through no of children having infections or allergies, difference of absent days in school due to infections or allergies,no of children for absent days in school due to infections or allergies, change in energy levels, physical fitness, strength and stamina and no of children having change in energy levels, physical fitness, strength &stamina & change in quality of life & Physicians Global evaluation on CGI-I Scale and safety and tolerability(180 days (6 Months))