CTRI/2021/05/033481招募中不适用
A Clinical Study on the Management of Essential Hypertension Grade 2 (Zaghtuddam Qawi Ibtidai- Darja Doem)with A Polyherbal Unani Formulation, A Randomized Standard Controlled Clinical Trial
Prof Rais Ur Rahman1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To develop safe efficacious and cost effective drug for the management of Essential hypertension from herbal source
研究概览
简要总结
Keeping view of higher prevalence of hypertension in India this trial is aimed for controlling blood pressure of such diagnosed Grade 2 essential hypertensive patient. It would be an randomized standard controlled study with a sample size of 60 patients.30 patients will be subjected to test drug ( Unani polyherbal formulation) and rest will be subjected to a allopathic medicine which is Telmisartan. Patient would be assessed weekly on the set parameters. Total duration of the protocol therapy would be 21 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patients of either sex with age limit from 18 years to 65 years with Essential Hypertension Grade 2 as per ACC criteria Patient willing to participate and sign the informed understood consent form.
排除标准
- •Secondary hypertension Patient with sign of end organ damage Patient taking OCP and long term use of steroids Pregnant & lactating women Renal and hepatic insufficiency other Cardiovascular disorder malignancy Patient who unwilling to sign the consent form.
结局指标
主要结局
To develop safe efficacious and cost effective drug for the management of Essential hypertension from herbal source
时间窗: baseline | 7th day | 14th day | 21st day
次要结局
- Expected Blood pressure target to achieve around 120/80 mm Hg plus minus 10 mm Hg during mental & physical rest(7 th day)
研究者
研究点 (1)
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