Clinical study for the effect of Zhenyuan capsule on Cardiopulmonary function in patients with stable Coronary Heart Disease with Qi deficiency and Blood stasis

Phase 4

• Conditions: Stable Coronary Heart Disease

• Registration Number: ITMCTR2000003300
• Lead Sponsor: Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Uptake(Peak VO2)(L/min);