Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Systolic (SBP) and diastolic (DBP) blood pressure reductions
研究概览
简要总结
The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.
详细描述
Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.
Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.
Research design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure >140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.
Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.
Discussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.
排除标准
- •Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.
研究组 & 干预措施
Antihypertensive drugs & Herbs
Thiazide diuretics and ACE inhibitor and β-blocker & Herbs for 8 weeks
干预措施: Herbs (Drug)
Antihypertensive drugs & Herbs
Thiazide diuretics and ACE inhibitor and β-blocker & Herbs for 8 weeks
干预措施: Antihypertensive drugs (Drug)
Antihypertensive drugs
Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks
干预措施: Antihypertensive drugs (Drug)
结局指标
主要结局
Systolic (SBP) and diastolic (DBP) blood pressure reductions
时间窗: Before treatment, 8 weeks during treatment
次要结局
- Cardiac event(Before treatment, 24 weeks follow-up)
- Death incident(Before treatment, 24 weeks follow-up)
- Scores for symptoms and signs(Before treatment, 8 weeks during treatment)
研究者
Ya YUWEN
Doctor
China Academy of Chinese Medical Sciences