CTRI/2019/05/019423招募中3 期
Randomized Controlled Clinical Trial to Evaluate the Efficacy of Amrutadi Yog in Essential Hypertension
未提供2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年1月7日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- reduction in blood pressure
研究概览
简要总结
This study is randomised controlled trial to evaluate the efficasy of ayurvedic formulation amrutadi yog which contains Amruta Tinospora cordifolia Willd. Miers.exHK.F.and Th., Gokshur Tribulus terrestris Linn, Jatamansi Nordostachys jatamansi (D.Don) DC. Parsik Yavani, Hysocymus niger Linn. Amalaki Phyllanthus emblica Linn Haritaki Terminalia chebula Retz. Trial drug dose 1 gm bid and control drug dose 20 mg once in day in the morning for 8 weeks for 110 patients in each group. study will be conducted in India. outcome of study will be asses on reduction of blood pressure and sign symptoms of hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Newly diagnosed patients of stage 1 essential hypertension with blood pressure systolic blood pressure is equal to and more than 140 mmHg and less than 160 mmHg and diastolic blood pressure is equal to and more than 90 mmHg and less than 100 mmHg.
排除标准
- •1.Patients receiving anti-hypertensive drug.
- •2.Complicated hypertensive cases.
- •Known case of Nephropathy, Left Ventricular Hypertrophy, heart block, Congestive Cardiac Failure, Coronary Artery Disease and retinopathy.
- •Patients suffering from Diabetes Mellitus and severe other illness like hepatic or renal failure.
- •3.Secondary, Accelerated and Malignant Hypertension 4.Patients taking steroids, oral contraceptive pills, estrogen replacement therapy or NSAIDS group of drug 5.Pregnant women or planning pregnancy within six months.
结局指标
主要结局
reduction in blood pressure
时间窗: 8 weeks
次要结局
- sign and symptoms of hypertension rlief(8 weeks)
研究者
研究点 (2)
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