CTRI/2022/11/047659尚未招募2 期
Phase II Non Randomised Clinical Study On Sooli Kanam (Bronchial Aathma) In Children WITH THE EVALUATION OF SIDDHA TRIAL DRUG SOOLI KANA NEI
Government Siddha medical college1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月12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
- It is assesed by reduction in clinical symptoms and Modified Asthma Scale before and after treatment
研究概览
简要总结
This is a single Non Randomized open Clinical Trial to study the safety and efficacy of Siddha trial drug Sooli kana nei (internal) is to be given about 2-5grams twice a day for 14 days to 40 patients.Clinical Trial conducted after conducting Pre Clinical oral toxicity study.The trial drug Sooli kana nei has mentioned in Pillai pini Maruthuvam Part 2.During the trial study related data will be recorded and documented.After the completion of trial all data will be statistically analysed.
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
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Cough without expectoration Dyspnea Running nose Chest tightness Wheezing.
排除标准
- •Primary complex Hypersensitivity Pneumonitis Lung Abscess Cystic fibrosis Bronchiolitis.
结局指标
主要结局
It is assesed by reduction in clinical symptoms and Modified Asthma Scale before and after treatment
时间窗: 14 days
次要结局
- It is assessed by comparing the safety parameters before and after treatment.(Along with this investigational changesof reduction in ESR level, Eosinophil counts, WBC and increase level of HB)
研究者
研究点 (1)
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