A single arm open stage IV clinical study on the immunomodulatory activity of Corina Plus Syrup® in children of age group 1-3 years for prevention of frequent upper respiratory diseases.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- In 45 days we expected to reduction in frequency and severity of frequent upper respiratory tract morbidity by about 40-50%
研究概览
简要总结
As per inclusion and exclusion criteria, study subject will be selected.
Whole research procedure and aim will be clearly informed to the parents of study subject and informed proxy consent will be obtained from the parents, case report format will be used to note the history and total information of study subject regarding upper respiratory tract diseases.
On day 0, case report format will be used to obtain the history of study subject, on the same day investigation will be done then treatment will be started with administration of Corina Plus Syrup® will be given to subjects. Follow up will be taken after every 15 days. Day of registration will be counted as day 0.
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
- 1.00 Year(s) 至 3.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with complaints of frequent (at least 3-4 epi/3 months) upper respiratory diseases.
排除标准
- •Children with LRTI, acute inflammatory pathology Children with debilitating respiratory diseases like TB 3Children with chronic inflammatory diseases, acute respiratory infection.
- •Children with groin temperature more than 100F at the time of recruited.
- •Children with anatomical and congenital disorders.
结局指标
主要结局
In 45 days we expected to reduction in frequency and severity of frequent upper respiratory tract morbidity by about 40-50%
时间窗: 45 days
次要结局
- Outcome expected is sustenance 0f reduction in frequency and severity of frequent upper respiratory tract morbidity by about 50-60%(90 days)
研究者
Dr Sheetal D Pudale
Bharati Vidyapeeth Deemed to Be University College of Ayurved Pune