Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
试验速览
- 阶段
- 3 期
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- systolic blood pressure
研究概览
简要总结
Despite of the development of new anti hypertensive agents, hypertension in elderly is still a big health problem. Nigella sativa seed extract, derived from a small plant originating in Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect but as it also shows anti-inflammatory and vasodilatory activity which are important contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it has a superior potential benefit for this population. We will conduct a randomized, double blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily will have anti-hypertensive effect in the blood pressure of elderly with hypertension.
详细描述
The study will be conducted in Geriatric Outpatient Clinic of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia.
Eligibility criteria are men and women over 60 years old and available to participate in the study for 4 weeks with blood pressure higher than 140/90.
Exclusion criteria are renal disease, hepatic failure, dementia and orthostatic hypotension and malignant hypertension.
Outcome measures are systolic and diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women more than 60 years old
- •Systolic Blood Pressure 140 mm Hg AND OR diastolic blood pressure 90 mmHg
- •Available during study duration (4 weeks)
排除标准
- •Renal failure
- •Hepatic failure
- •Orthostatic hypotension
- •Malignant hypertension
结局指标
主要结局
systolic blood pressure
时间窗: 4 weeks
We aim to measure the difference in systolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract in elderly with hypertension
次要结局
- diastolic blood pressure(4 weeks)