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临床试验/ITMCTR2200005893
ITMCTR2200005893尚未招募1 期

Clinical Study of Qixuetongzhi Formula Improving The Prognosis of Stable Coronary Heart Disease

Xiyuan Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新:
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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