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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003300

Enrollment

Unknown

Registered

2020-05-11

Start date

2020-06-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Coronary Heart Disease

Interventions

Control group:Placebo

Experimental group:Zhenyuan Capsule

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Peak Oxygen Uptake(Peak VO2)(L/min);	—

Countries

China

Contacts

Public ContactWang Chenglong

Graduate School of Chinese Academy of Traditional Chinese Medicine

WCL796@163.COM+86 10-62835630

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026