Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- change in the maximum volume of O2 consumption
研究概览
简要总结
Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health
详细描述
90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.
One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.
The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.
The secondary endpoint is:
- Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
- Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
- The maximum walking distance of 6-minute walk test;
- Changes of Seattle Angina Questionnaire;
- Hamilton Depression Scale/ Hamilton Anxiety Scale.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 ~ 75, gender is not limited
- •Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
- •Sign the informed consent voluntarily
排除标准
- •History of hospitalization for acute coronary syndrome in past 3 months
- •Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（<90/60mmHg）
- •History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
- •In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
- •Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate <60bpm) or atrioventricular block
- •Severely allergic constitution, known or likely to be allergic to the test drug or its components
- •Known bleeding tendency or hemorrhagic disease
- •Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
- •Any other situations that researchers believe may affect the clinical research
研究组 & 干预措施
Treatment group
The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
干预措施: Yangxinshi pill (Drug)
Treatment group
The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
干预措施: conventional coronary heart disease medicine (Drug)
Control group
The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
干预措施: conventional coronary heart disease medicine (Drug)
Control group
The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
干预措施: Placebos (Drug)
结局指标
主要结局
change in the maximum volume of O2 consumption
时间窗: from baseline to 6 months
measured by gas analyzer
次要结局
- change in exercise tolerance(from baseline to 6 months)
- change in left ventricular ejection fraction (in percentage)(from baseline to 6 months)
研究者
Xiaoping Meng
chief physician
Affiliated Hospital of Changchun University of Chinese Medicine