Chronic Coronary Syndrome
Conditions
Interventions
Control Group:Placebo
Experimental Group:Compound Ciwujia Granules
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for chronic coronary syndrome; 2. Has strictly followed the recommended treatment plan as recommended by clinical guidelines, maintaining the original treatment plan stable within 2 weeks and without adding any traditional Chinese medicine; 3. Age 18 to 80 years old; 4. Capable of undergoing CPET testing; 5. Understands and complies with the research procedures and methods, voluntarily participates in this study, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who planned to undergo revascularization procedures (such as PCI, CABG), implantable devices (such as ICD, CRT, etc.) or surgical operations within 3 months before the study or during the study period; 2. Those with severe cardiac or pulmonary dysfunction (NYHA cardiac function III or IV; or left ventricular ejection fraction (LVEF) 120 beats per minute; (5) Poorly controlled hypertension (treatment-induced systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) or hypotension (systolic blood pressure = 9.5%; (2) Alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal value; (3) Total bilirubin >= 1.5 times the upper limit of the normal value; (4) eGFR calculated according to the CKD-EPI formula < 40 ml/min/1.73 m^2; (5) Hemoglobin Hb < 90 g/L; 5. Those with an expected survival period of less than 1 year for malignant tumors or other serious diseases; 6. Those with mental abnormalities or unable to cooperate; 7. Pregnant or lactating women, or those with a fertility need within 1 month after the first administration of the study drug to the last administration; 8. Those who have received other clinical research drugs or medical devices within 1 month before screening or within 5 half-lives (whichever is longer); 9. Those who are participating in other drug or device clinical studies; 10. Those who are known to be allergic to Compound Codonopsis Granules and its excipient components; 11. Those who are using other Chinese patent medicines and cannot discontinue the medication; 12. The investigator believes that the subject has any conditions that are not suitable for enrollment; 13. Those who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage improvement of VO2max compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Incidence Rate of Major Adverse Cardiovascular Events (MACE);Percentage Improvement in Maximum Oxygen Pulse;Percentage Improvement in Anaerobic Threshold;Rate of Change in Oxygen Pulse Curve Slope;Seattle Angina Questionnaire Score; | — |
Countries
China
Contacts
Public ContactQi Zhang
Shanghai East Hospital
Outcome results
None listed