CTRI/2020/01/022659已完成2 期
An open label clinical trial to evaluate the Efficacy of Kuka Cough Syrup in the Patients Suffering with Kasa (Acute Cough and Throat Irritation)
Multani Pharmaceuticals Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- VCD scale
研究概览
简要总结
Itis an open label, single armed, single center, prospective, interventionalclinical study to evaluate the efficacy of Kuka cough syrup in the patientssuffering from acute cough and throat irritation. This study will be conductedin Panchakarma Department, NIA, Jaipur, Rajasthan. It will be advised tosubjects to take the syrup four times a day for 7 days. The primary outcomemeasure will be to assess the efficacy of Kuka cough syrup in subjects withacute cough and throat irritation after 7 days of treatment. Time points willbe Day 0 (Baseline), Day 3 and Day 7. Follow up of the subjects will be after 7days, to check reoccurrence of the disease.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •History of acute nonproductive cough due to any cause.
- •Subjects who are willing to give informed consent and ready to comply with the protocol.
- •Subjects who are ready to provide regular follow up until the completion of the study.
排除标准
- •Participants with a history of acute lower respiratory tract infections such as pneumonia, bronchitis whooping cough, chronic obstructive pulmonary disease/asthma, tuberculosis, systemic bacterial infections for which specific drug therapy required Any underlying lung pathology such as lung abscess or cystic fibrosis, individuals with a history of myocardial infarction within 4 weeks prior to enrollment;.
结局指标
主要结局
VCD scale
时间窗: Day 0 and 7
次要结局
- Time to relief from cough and throat irritation for all the first morning doses, duration of relief from symptoms for all first morning doses in all the subjects, drowsiness, and Physician’s Global Assessment of efficacy evaluated at visit 4 in both the treatment groups on VCD scales(14 days)
研究者
研究点 (1)
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