CTRI/2023/01/048744尚未招募2/3 期
An Experimental and a pilot clinical study to evaluate the Jwaraghna(antipyretic) effect of Kiratadi Syrup in school going children
Dr.Shivpratap Biradar1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年3月15日最近更新:
适应症
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Reduction in Axillary temperature of the patients
研究概览
简要总结
This is single arm study.The aim of study is to observe the antipyretic effect of Kiratadi Syrup in school going children.Total 12 patient will be enrolled and 1.40ml/kg syrup will be given in divided doses thrice in a day after meal. The age group taken for the study is 6 to 12 years of school going children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between the age of 6-12 years irrespective of gender and socioeconomic status.
- •Children with signs and symptoms of jwara (fever).
- •Children with fever between 37.4(99.3â°f)to 38.3â°c(100.94â°f) 4)children suffering from fever for less than 48hr.
- •Children whose parents are ready to participate in the clinical trial by giving informed written assent.
排除标准
- •Children with fever >38.3â°C(100.94â°F) 2)Children suffer from Fever for more than 48hr.
- •Children suffering from the common cold, and cough.
- •Vomiting diarrhea fever with rash and the common conditions 4)K/C/O Systemic illness.
- •Patients with history of Febrile Convulsions.
结局指标
主要结局
Reduction in Axillary temperature of the patients
时间窗: 5 days study with 0,3rd and 5th day
次要结局
- To observe the adverse effect of Kiratadi Syrup(5 days study with 0,3rd and 5th day)
研究者
研究点 (1)
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