NCT02124473已完成2 期
Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Homeopathy in Resistant Arterial Hypertension
Macmillan Research Group UK2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Daytime systolic and diastolic pressure
研究概览
简要总结
Resistant hypertension (RHTN) is a common clinical problem faced by both primary care clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular events and mortality compared with patients with more easily controlled hypertension. In addition, RHTN is often complicated by metabolic abnormalities.
Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the impact on resistant hypertension. The aim of this trial was to evaluate individualized homeopathy on BP in patients with resistant hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years with resistant arterial hypertension.
- •Office systolic BP >140 mm Hg or diastolic BP >90 mm Hg despite being treated with at least 3 antihypertensive drugs, including a diuretic.
- •Patients with diabetes or chronic kidney disease (defined as serum creatinine >133 μmol/L or proteinuria >300 mg/day) if the office BP was >130/80 mm Hg.
排除标准
- •Severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg) who needed an immediate adjustment of treatment,
- •Renal insufficiency with serum creatinine >180 μmol/L or glomerular filtration rate <40 mL/min calculated by the Modification of Diet in Renal Disease formula,15 hyperkalemia >5.4 mmol/L, hyponatremia <130 mmol/L, and porphyria;
- •Pregnant or lactating women or women of fertile age not using effective contraception;
- •Patients with known prior hypersensitivity to the drug Verospiron (spironolactone; Richter Gedeon Ltd) or who are currently using any aldosterone antagonist.
结局指标
主要结局
Daytime systolic and diastolic pressure
时间窗: Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months
次要结局
- 24-hour systolic and diastolic BP(Change from Baseline in 24-hour blood pressure at 3 months)
研究者
研究点 (2)
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