CTRI/2018/08/015228已完成3 期
Effects of homoeopathic intervention in stage I essential hypertensive patients: a randomized double blind, placebo controlled trial.
Central Council for Research in Homoeopathy7 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2014年11月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 7
- 主要终点
- 1 To evaluate the mean change in systolic and diastolic blood pressure from baseline at every month for 3 months from baseline as per routine method.
研究概览
简要总结
The study will be a randomized double blind placebo controlled trial for a period of 3 months.
Group 1: Individualized homoeopathy+ life style modifications (IH+LSM).
Group 2: Control (life style modification- diet and exercise)
Purpose of the study is to evaluate the mean changes in Stage I hypertensive patients with respect to systolic and diastolic BP in clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •30 to 60 yrs 2.Both genders 3.Essential hypertension of stage I (SBP 140-159; DBP 90-99) 4.Patients who were not on any anti-hypertensive medicine since last 1 month.
- •5.Patients willing to participate in the study.
排除标准
- •1.Patients with secondary hypertension of any etiology.
- •2.Patients with pre hypertension, stage II hypertension as per JNC 7 criteria.
- •3.Known Diabetics.
- •4.Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect or known cases of cardiac diseases.
- •5.Patients with systemic illness 6.Patients receiving any drugs known to affect blood pressure 7.Patients judged to have a history of alcohol or drug abuse 8.Women who are taking contraceptive pills, pregnancy and lactating mother.
- •9.Patients suffering from hypothyroidism.
- •10.Unable or unwilling to give informed consent.
结局指标
主要结局
1 To evaluate the mean change in systolic and diastolic blood pressure from baseline at every month for 3 months from baseline as per routine method.
时间窗: every month for 3 months
2 To evaluate the changes in Ambulatory BP at 3rd month from baseline.
时间窗: every month for 3 months
次要结局
- Percent of patients meeting the goal BP of SBP≤ 135mmHg and DBP ≤85 mmHg in patients of both the groups(3 months)
研究者
研究点 (7)
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