NCT06852079招募中3 期
Safety & Efficacy of Qurs E Fishar in Mild to Moderate Hypertensive Patients in Pakistan
Abdul Bari1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2023年12月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
The herbal medicine Qurs-e-Fishar to treat mild to moderate High blood pressure or hypertension comprises of Rauwolfia serpentina. A product of Hamdard Laboratories (Waqf) Pakistan.
A Phase III Safety & Efficacy Open-label, Single-Arm, Interventional, Multicenter, Study in mild to moderate hypertensive, adults (30 to 60 years of age) prescribed with study product for 12 weeks (84 days).
Primary End Points:
- Reduction in diastolic blood pressure less than 130 / 80 mmHg at the end of the study period (accepted by WHO) or if there was a fall of 20 / 10 mmHg or more in diastolic blood pressure as compared to baseline.
- Type, frequency and severity of ADRs during the study period.
Secondary End Points:
- Compliance of the prescribed study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to sign ICD
- •Participant(s) are willing and able to fulfill the requirements of the study protocol
- •Mild to moderate hypertensive
- •Mild hypertension range (140-159/90-99 mm Hg)
- •Moderate hypertension range (160-179/100-109 mm Hg)
- •Be between the age of 30 to 60 year
排除标准
- •Patients with recent history of following will be excluded:
- •Severe hypertension,
- •Congestive cardiac failure,
- •Left ventricular failure,
- •Myocardial ischemia,
- •Renal failure or
- •Cerebrovascular accidents
研究组 & 干预措施
Effect of Qurs e Fishar on Hypertension
Experimental
干预措施: Qurs e Fishar (Other)
结局指标
主要结局
Blood Pressure
时间窗: 12 weeks
Blood pressure (in mmHg) will be measure at baseline and again at first follow-up (4th week), than at second follow-up (at 8th week) the end of treatment (12th week).
次要结局
未报告次要终点
研究者
Abdul Bari
Co-Principal Investigator
Hamdard University
研究点 (1)
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