A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shexiang Baoxin Pill on Coronary Microvascular Dysfunction
试验速览
- 阶段
- 4 期
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- the difference of HRR between the experimental group and the placebo group was significant
研究概览
简要总结
Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality of life were also observed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80, male or female;
- •Selective coronary angiography or coronary CTA showed that the diameter of coronary artery ≥ 2.5mm, the degree of stenosis < 50%, without myocardial bridge;
- •They were able to perform treadmill exercise, and the treadmill test (EET) was positive;
- •Angina pectoris was found;
- •Patients are willing to follow up and sign informed consent; All the above criteria should be met.
排除标准
- •Coronary heart disease complicated with hypertrophic cardiomyopathy;
- •There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;
- •Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);
- •Mental disorders and mental diseases;
- •Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;
- •Contraindications of Shexiang Baoxin Pill: forbidden for pregnant women;
- •Those who have known history of allergy to Shexiang Baoxin Pills;
- •Recently, the patient has taken Shexiang Baoxin Pill and other anti ischemic traditional Chinese medicine regularly, or it contains borneol, toad venom and other ingredients in Shexiang Baoxin Pill;
- •Combined with frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation, sinoatrial block, atrioventricular pathway block, left bundle branch block and right bundle branch block, which may affect the judgment of exercise ECG results;
- •Researchers think that there are other factors that are not suitable to participate in the trial; If one of the exclusion criteria is met, it can be excluded.
研究组 & 干预措施
Experimental group
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up
干预措施: MUSK pill (Drug)
Placebo group
The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up.
干预措施: MUSK pill (Drug)
结局指标
主要结局
the difference of HRR between the experimental group and the placebo group was significant
时间窗: At the end of treatment (8 weeks (± 1 week))
Definition of abnormal heart rate recovery: peak HR during exercise - HR one minute into recovery at the end of exercise is defined as abnormal heart rate recovery when HR one minute into recovery is less than 12 beats / min.
次要结局
未报告次要终点