ITMCTR2200005893尚未招募1 期
Clinical Study of Qixuetongzhi Formula Improving The Prognosis of Stable Coronary Heart Disease
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 15 至 75（—）
- 性别
- All
入选标准
- •(1)Coronary angiography or coronary computed tomographic angiography shows at least one major coronary artery luminal diameter stenosis = 50% or a history of myocardial infarction, or be in stable condition more than one month after percutaneous coronary intervention or coronary artery bypass grafting.
- •(2)Left ventricular ejection fraction = 40%.
- •(3)Canadian Cardiovascular Society grading of angina pectoris I-II.
- •(4)Traditional Chinese Medicine syndrome of qi deficiency and blood stasis, liver qi stagnation.
- •(5)Aged 18-75 years.
- •(6)Meet low to medium risk stratification of cardiac rehabilitation, and could take part in cardiopulmonary exercise test;
- •(7) Provide written informed consent.
排除标准
- •(1)Acute myocardial infarction, unstable angina pectoris, underwent PCI or CABG within the past one month.
- •(2)Meet absolute and relative contraindications of CPET.
- •(3)Patients who have taken drugs for tonifying qi or promoting blood circulation or regulating qi, or have participated in other clinical trials during the past month.
- •(4)Renal insufficiency, serum creatinine >2.5 mg/dl (220umo/l) in males and >2.0 mg/dl (175umo/l) in females.
- •(5)Patients with severe liver disease and/or alanine aminotransferase, aspartate transaminase >3 times the upper limit of normal.
- •(6)New York Heart Association class ? or recurrent malignant arrhythmia.
- •(7)Complicated with chronic obstructive pulmonary disease, pulmonary infection, or respiratory failure.
- •(8)Diabetic patients with random blood glucose =13.7mmol/L or glycosylated hemoglobin =9.5%.
- •(9)Pregnancy, preparing for pregnancy and breastfeeding.
- •(10)Patients with acute cerebrovascular disease, malignant tumour, life expectancy less than 1 year, serious hematopoietic system disease.
- •(11)Patients with psychosis or PHQ-9 or GAD-7 scale score = 15 or those who have taken anti-anxiety and depression drugs within the past 1 month;
- •(12)Patients who are allergy to known ingredients of the study drug.
研究者
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