CTRI/2021/11/037810尚未招募2 期
Phase II non randomized open clinical evaluation of Siddha medicine elathi chooranam for the management of Uratha pitha vatham (Hypertension)
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: 2021年11月11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
- Primary outcome is mainly assessed by reducing blood pressure up to 10-20 mmHg systolic and 5-10 mmhg in diastolic level
研究概览
简要总结
This is single Non randomized open clinical trial to study the safety and efficacy of siddha trial drug ELATHI CHOORANAM. The trial drug is given 5grams twice a day for 48 days. Clinical trial is conducted after conducting pre clinical toxicity study. The trial drug ELATHI CHOORANAM is mentioned in sarabenthira vaithiya muraikal. During the trial all the 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
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary hypertension Giddiness Sweating Nausea Headache Fatigue Blood pressure level140/90mmhg.
排除标准
- •Secondary hypertension Hypertension in pregnancy Hypertension with diabetes mellitus Blood pressure above 180/100.
结局指标
主要结局
Primary outcome is mainly assessed by reducing blood pressure up to 10-20 mmHg systolic and 5-10 mmhg in diastolic level
时间窗: 48days
次要结局
- Secondary outcome is assessed by comparing the safety parameters before and after treatment(48 days)
研究者
研究点 (1)
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