CTRI/2020/10/028491尚未招募2 期
PhaseII non randomized clinical study on sooli kanam (Bronchial asthma) with evaluation of siddha trial drug - Kannaiku atthi nei
Government siddha medical college chennai1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- clinical assesment of bronchial asthma is carried out on the basis of modified asthma scale, and comparing the clinical symptoms before and after treatment
研究概览
简要总结
This is an phase II open single non randomized study to evaluate the official Siddha formulaiton "Kannaiku atthi nei" internally for Bronchial asthma (sooli kanam) . The trial drug is given 2 to 5 ml twice a day for 21 days. clinical trial conducted after conducting pre-clinical toxicity study. The trial drug Kannaiku atthi nei is mentioned in kumbamuni balavagadam book. During the trial study related data will be recorded and documented. after the completion of the trial all the data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •age 3 to 12 years cough without expulsion wheezing dyspnea rhinitis.
排除标准
- •primary complex hypersensitivity pneumonitis lung abscess cystic fibrosis bronchiolitis.
结局指标
主要结局
clinical assesment of bronchial asthma is carried out on the basis of modified asthma scale, and comparing the clinical symptoms before and after treatment
时间窗: 21 days
次要结局
- it is assessed by comparing the safety parameters before and after treatment(21 days)
研究者
研究点 (1)
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