chronic coronary syndrome (Qi deficiency and blood stasis syndrome)
Conditions
Interventions
experimental group:Experimental group: conventional treatment + Yangxinshi tablet, 3 tablets/time, 3 times/day
control group:Control group: conventional treatment + Yangxinshi tablet simulation agent, 3 tablets/time, 3 times/day
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for chronic coronary syndrome (CCS), and at the same time, meet the diagnosis of stable coronary heart disease (including more than 1 year after revascularization) with a degree of coronary artery stenosis>=50% through angiography or CTA examination; 2. Meet the criteria for traditional Chinese medicine syndrome of qi deficiency and blood stasis; 3. The METs value measured through cardiopulmonary exercise test (treadmill) is less than 5; 4. Age range from 18 to 75 years old (including threshold), gender is not limited; 5. Understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with lower limb dysfunction, intermittent claudication, or severe leg pain who are unable to participate in cardiopulmonary exercise assessment; 2. Acute coronary syndrome, or within 1 month after percutaneous coronary intervention (PCI), or within 3 months after coronary artery bypass grafting (CABG); 3. Those with severe primary diseases such as liver, kidney, hematopoietic system, acute infectious diseases, mental illness, or other diseases that are not suitable for cardiopulmonary exercise test; 4. Have a blood flow reconstruction plan within one month; 5. The degree of stenosis in the left main trunk is = 50% of the lesion, or the diameter of stenosis in the proximal segment of LAD is>=90%, and no PCI or CABG surgery has been performed; 6. Patients with absolute and relative contraindications for cardiopulmonary exercise testing (see Annex 11 for details); 7. NYHA heart function level III and IV; 8. Patients with concurrent acute cerebrovascular disease; 9. Uncontrolled hypertension with systolic blood pressure>=160mmHg and diastolic blood pressure>=100mmHg; 10. Individuals found to be in a state of severe anxiety or depression according to the scores of the Generalized Anxiety Disorder Scale (GAD-7) and the Depression Screening Scale (PHQ-9); 11. Subjects who have allergic reactions or abnormal drug reactions to the investigational drug and any of its excipients; 12. Women of childbearing age who are pregnant or breastfeeding, have a fertility plan within six months, have tested positive for pregnancy, and are unable to take effective contraceptive measures during the trial period; 13. Those who have regularly taken Yangxin Tablet or Chinese herbal decoction with similar efficacy or traditional Chinese patent medicines and simple preparations in the past 7 days (see Annex 12 for the name of traditional Chinese patent medicines and simple preparations); 14. Those who have participated in other clinical trials within the past three months; 15. Researchers believe that it is not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiopulmonary Exercise Test (treadmill) : (Metabolic equivalent and peak oxygen uptake); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiopulmonary exercise test (treadmill): (anaerobic threshold, oxygen pulse, maximal exercise ventilation, start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test);CCS angina classification;Seattle Angina Questionnaire;Pittsburgh Sleep Quality Index (PSQI);General Anxiety Disorder-7 (GAD-7);Patient Health Questionnaire (PHQ-9);Traditional Chinese medicine (TCM) Syndrome Score;Hospitalization within 6 months of taking the medicine: (total hospitalization time and hospitalization frequency); | — |
Countries
China
Contacts
Public ContactWang Xian
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed