Clinical study for the effect of Zhenyuan capsule on Cardiopulmonary function in patients with stable Coronary Heart Disease

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1. Results of coronary angiography or spiral CT: coronary stenosis >= 50%, or clear history of myocardial infarction, or stable condition more than one month after ACS treatment (PCI, CABG);
•2. Patients with LVEF >= 40%;
•3. Patients with angina I-II (CCS grade);
•4. Patients with Qi deficiency and blood stasis syndrome;
•5. Patients aged 18 to 75 years;
•6. The patients who are in line with the risk stratification of coronary heart disease and have low risk of cardiac rehabilitation can be rehabilitated by exercise cardio pulmonary;
•7. Patients willing to sign informed consent.

•1. Patients with acute myocardial infarction, unstable angina, or within one month after PCI or CABG;
•2. Patients with absolute and relative contraindications for cardiopulmonary exercise test;
•3. Patients who took Zhenyuan capsule in the last month or who participated in other clinical trials in the last month;
•4. In the patients with renal insufficiency, serum creatinine was more than 2.5mg/dl in men and more than 2.0mg/dl in women;
•5. Patients with obvious liver disease or ALT and AST were 3 times higher than the upper limit of normal;
•6. New York Heart Function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
•7. Patients with chronic obstructive pulmonary disease or even respiratory failure, or patients with pulmonary infection;
•8. Patients with diabetes mellitus whose blood glucose >=13.7mmol/l or HbA1c was >= 9.5%;
•9. Pregnant or preparing pregnant women and lactating women;
•10. Patients with acute cerebrovascular disease; malignant tumor or patients with life expectancy less than 1 year; patients with severe hematopoietic system disease; patients with severe mental disease;
•11. Patients who are allergic to known components of the study drug.

发起方

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine