NCT03633890Unknown4 期
A Randomized, Double-Blind, Placebo-Controlled Trial for DaZhu Rhodiola Rosea Capsule in the Treatment of Coronary Artery Disease With Angina Pectoris
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Seattle Angina Questionnaire (SAQ) angina frequency
研究概览
简要总结
This study aims to evaluate the efficacy and safety of traditional Chinese medicine DaZhu Rhodiola Rosea Capsule for treatment of coronary artery disease by observing angina symptoms, exercise capacity, and quality of life.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old
- •Coronary heart disease with grade Ⅱ or Ⅲ stable or unstable angina (≥ 2 times per week), or residual angina-like symptoms 1 month to 1 year post percutaneous coronary intervention (PCI) or 3 months to 1 year post coronary artery bypass surgery (CABG)
- •Written informed consent
排除标准
- •Acute myocardial infarction within 1 month before admission
- •Patients who plan to undergo revascularization in the next 3 months
- •Congestive heart failure, acute myocarditis or pericarditis, thrombophlebitis, pulmonary embolism, or severe neurosis within 3 months prior to admission
- •Patients with uncontrolled high blood pressure (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg), severe cardiopulmonary insufficiency (cardiac function grade Ⅲ, Ⅳ or left ventricular ejection fraction (LVEF) < 40%), severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, degree Ⅱ type Ⅱ and degree Ⅲ atrioventricular block, etc.)
- •Severe liver, kidney and hematopoietic system dysfunction or psychosis (serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the normal upper limit, or serum creatinine > 1.5 times the normal upper limit)
- •History of bleeding or treatment with warfarin
- •Implanted pacemakers
- •Pregnant or lactating women
- •Allergic to study drugs
- •Legal disability (blindness, deafness, dumbness, intellectual disability, mental disability, physical disability)
- •Patients who participated in other clinical trials within 3 months
研究组 & 干预措施
DaZhu Rhodiola Rosea Capsule
Experimental
干预措施: DaZhu Rhodiola Rosea Capsule (Drug)
DaZhu Rhodiola Rosea Simulation Capsule
Placebo Comparator
干预措施: DaZhu Rhodiola Rosea Simulation Capsule (Drug)
结局指标
主要结局
Seattle Angina Questionnaire (SAQ) angina frequency
时间窗: week 8
Scored from 0 to 100, with higher scores indicating better health status
次要结局
- SAQ angina stability(week 8)
- visual analogue scale (VAS) score(week 8)
- 36-item Short Form Health Survey (SF-36) score(week 8)
- SAQ physical limitation(week 8)
- SAQ treatment satisfaction(week 8)
- SAQ disease perception(week 8)
- Walking distance by 6-minute walking test(week 8)
- Frequency of angina(week 8)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital
研究点 (1)
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