A two arm randomized, open labeled, prospective, multi-centre, clinical study to evaluate efficacy and safety of Dabur Ratnaprash in health & immunity related parameters
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Assessment of quality of life (QoL) and number of episodes, severity and duration of illness during the study period
研究概览
简要总结
The study will be a multicentre, randomized, open label, parallel-group study which is intended to evaluate the safety and efficacy of Dabur Ratnaprash in health and immunity parameters. Healthy subjects in the age group of 18-60 years will be randomized to either of the two groups i.e. Ratnaprash followed by milk and only milk group twice daily in 1:1 ratio.Theglass of milk may be between 100-200 ml. Treatment period will be of 90 days with total visit of 5 visits including screening. Total completers for the study is planned to be 100 subjects. The following parameters will be evaluated like Physical examination, Vital signs, Assessment of level of Energy and overall health status, physical fitness, level of endurance or stamina and physical strength, level of stress, Physician’s Global evaluation, Laboratory parameters for safety and immunity and Palatability etc at various intervals of time.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Male and female subjects aged 18 to 60 years (both the ages inclusive) •Ready to provide written informed consent •No history of any known allergy with Chyawanprash like products or any of the ingredientts of the Ratnaprash •Willing to come for the follow up visits for evaluation.
排除标准
- •â€¢Presence of clinically significant abnormal laboratory, ECG or X-ray findings during screening.
- •â€¢Patients with known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI) •Patients participated in another clinical drug trial within 3 months before recruitment in this trial •Any other medical condition that in the Investigators opinion would preclude patient participation •Pregnant and breast feeding women and women of child bearing age refusing to use contraceptive measures •Immunologically compromised individuals.
结局指标
主要结局
Assessment of quality of life (QoL) and number of episodes, severity and duration of illness during the study period
时间窗: 90 days (3 months)
次要结局
- To assess level of Energy and overall health status, physical fitness, level of endurance or stamina and physical strength, level of stress, Physician’s Global evaluation, Laboratory parameters for safety and immunity and Palatability(90 days (3 months))