Coronary heart disease stable angina pectoris(Qi Stagnation and Blood Stasis Syndrome)
Conditions
Interventions
Experimental group:Xintongkang Tablets + Xinkeshu capsule analog agent
Control group:Xinkeshu capsule + Xintongkang capsule analog agent
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 85 years old (including 18 and 85 years old) with no restriction on gender; (2) Meeting the Western medical diagnostic criteria for stable angina pectoris of coronary heart disease; (3) Meeting the Canadian Cardiovascular Society (CCS) angina pectoris classification of Grade ?-?; (4) Meeting the TCM syndrome criteria for qi stagnation and blood stasis syndrome; (5) Having a course of angina pectoris of more than 2 months and with =2 angina pectoris attacks per week during the run-in period; (6) Voluntarily participating in the trial and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Complicated with clinically significant valvular heart disease congenital heart disease pulmonary hypertension chronic obstructive pulmonary disease (COPD) stroke dissecting aneurysm hypertrophic cardiomyopathy acute myocarditis or pericarditis; (2) Complicated with other severe cardiopulmonary insufficiency or severe arrhythmias; (3) Complicated with chest pain caused by severe neurosis climacteric syndrome hyperthyroidism cervical spondylosis osteoarthropathy biliary heart disease gastroesophageal reflux or chest pain caused by respiratory system diseases; (4) Patients with unstable angina pectoris within 3 months before screening; (5) Patients with myocardial infarction or infarct symptoms within 3 months before screening; (6) Patients who have undergone coronary revascularization received a cardiac pacemaker or have a recent surgical plan within 3 months before screening; (7) Patients with other diseases that contraindicate treadmill exercise testing (only for those undergoing treadmill exercise testing); (8) Patients with severe primary diseases or functional disorders of the hematopoietic system digestive system immune system etc.; (9) Patients with severe liver or kidney diseases or abnormal liver and kidney function tests (ALT or AST = 2×ULN Scr > 1.5×ULN); (10) Patients with poorly controlled blood glucose (glycated hemoglobin > 7.5%); (11) Patients with severe hypertension whose blood pressure remains = 180 mmHg/110 mmHg after drug control or hypotension (resting sitting blood pressure) < 90 mmHg/50 mmHg; (12) Patients with mental illness alcohol dependence or a history of drug abuse; (13) Pregnant or lactating women or male/female patients who are unwilling to take contraceptive measures during the trial and within 1 month after the trial ends; (14) Patients with a history of allergies to multiple drugs or allergies to the components of the study drug; (15) Patients who participated in other clinical trials within 3 months before this trial; (16) Patients deemed unsuitable for participation in this study by the researchers for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Seattle Angina Questionnaire (SAQ) scores from baseline after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosage and Discontinuation/Reduction Rate of Nitroglycerin;The change in Seattle Angina Questionnaire (SAQ) scores from baseline after 4 weeks of treatment;The changes in angina pectoris symptom scores and angina pectoris pain intensity scores from baseline after 4 and 8 weeks of treatment;Changes in treadmill exercise test indicators from baseline after 8 weeks of treatment (the number of test cases for this detection is 120);The changes in the total score of TCM syndromes and the scores of individual symptoms from baseline after 4 and 8 weeks of treatment;The changes in the number and duration of angina pectoris episodes from baseline at the 2nd 4th 6th and 8th weeks of treatment; | — |
Countries
China
Contacts
Public ContactShang Juju
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed