Efficacy and Safety of Yangxinshi Tablet in Improving Exercise Tolerance in Patients With Chronic Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome):A Randomized, Double-blind,Placebo-parallel-controlled,Multicenter Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
研究概览
简要总结
This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in patients with chronic coronary syndrome (CCS).
详细描述
The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of conventional treatment can improve exercise tolerance of patients with chronic coronary syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS patients were randomly divided into two groups. In addition to conventional treatment, the experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All the following criteria must be met to participate in the study:
- •Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed tomography angiography (CTA) (including patients with more than 1 year of revascularization)
- •Meet the TCM standard of Qi deficiency and blood stasis syndrome
- •MET < 5 measured by cardiopulmonary exercise test (treadmill)
- •Age between 18 and 75 years (including both age limits), with no limitation on sex
- •Understanding and voluntarily signing the written informed consent
排除标准
- •All the following criteria must not be met to participate in the study:
- •Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests
- •Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)
- •Individuals with serious primary diseases related to the liver, kidney, and hematopoietic system, acute infectious diseases, and mental illness and individuals with other diseases who are not suitable for cardiopulmonary exercise tests
- •Individuals with a revascularization plan within a month
- •Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG
- •Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details)
- •Individuals with New York Heart Association (NYHA) cardiac function class III and IV
- •Individuals with acute cerebrovascular disease
- •Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg
- •Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9
- •Individuals with allergies or abnormal drug reactions to the test drugs
- •Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant within six months, have a positive pregnancy test, and cannot take effective contraceptive measures during the study period
- •Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary Chinese medicines with similar curative effects within the past 7 days (please refer to Appendix 12 for the names of proprietary Chinese medicines)
- •Individuals who have participated in other clinical trials within the past 3 months
- •Individuals unsuitable for the clinical trials, as determined by the researchers
研究组 & 干预措施
Treatment group
Yangxinshi tablets
干预措施: Yangxinshi tablet (Drug)
Control group
Yangxinshi tablet simulants
干预措施: Yangxinshi tablet simulants (Drug)
结局指标
主要结局
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
时间窗: 24 weeks
MET=Metabolic Equivalent of Task
次要结局
- electrocardiogram (ECG)(24 weeks)
- CCS angina classification(24 weeks)
- oxygen pulse(24 weeks)
- Patient Health Questionnaire (PHQ-9)(24 weeks)
- Traditional Chinese medicine (TCM) Syndrome Score(24 weeks)
- maximal exercise ventilation(24 weeks)
- anaerobic threshold(24 weeks)
- Seattle Angina Questionnaire(24 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(24 weeks)
- General Anxiety Disorder-7 (GAD-7)(24 weeks)
- Hospitalization within 6 months of taking the medicine(24 weeks)
研究者
Wang Xian
Professor
Dongzhimen Hospital, Beijing