Coronary Heart Disease
Conditions
Interventions
Control group:placebo,1 bag/time, 3 times/day, taken with boiling water.
Experimental Group:.:Wuwei Yixin Granules,1 bag/time, 3 times/day, taken with boiling water.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Meets the Western medical diagnostic criteria for stable angina pectoris in coronary heart disease. Canadian Cardiovascular Society (CCS) angina severity classification is Grade I–II. Meets the traditional Chinese medicine diagnostic criteria for Qi-Yin deficiency and phlegm-stasis interference syndrome. Frequency of angina attacks is =2 times per week during the screening/lead-in period. Patients who have previously used beta-blockers or calcium channel blockers must have been on a regular regimen for at least 1 month. Age between 18 and 70 years (inclusive) with no gender restrictions. Informed consent and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: Angina caused by other conditions such as severe aortic stenosis or insufficiency rheumatic coronary arteritis syphilitic aortitis etc.; patients with valvular heart disease cardiomyopathy or other organic heart diseases (e.g. severe heart disease uncontrolled symptomatic heart failure); hyperthyroidism emphysema or other severe diseases; cervical spondylosis cardiac neurosis etc.; and chest pain caused by severe thoracic diseases pulmonary diseases intercostal neuralgia somatic symptoms due to psychiatric diseases esophageal diseases or gastrointestinal ulcers. Presence of other conditions that may affect ST-T changes on electrocardiogram (ECG) such as left ventricular hypertrophy left bundle branch block Wolff-Parkinson-White syndrome ventricular paced rhythm effects of digitalis drugs or electrolyte disturbances (as determined by the investigator to be clinically significant). Patients with persistent atrial fibrillation. Patients with severe osteoarthritis with limited mobility. Patients with prolonged QT interval (QTc > 480 ms) or cardiac ultrasound ejection fraction (EF) 180 mmHg or diastolic blood pressure > 110 mmHg) or diabetes (HbA1c > 8.5%). Patients with serum creatinine levels exceeding the upper limit of normal or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than twice the upper limit of normal. Pregnant women women planning to become pregnant within 6 months or breastfeeding women. Patients with psychiatric disorders or cognitive impairments deemed by the investigator to be unable to cooperate. Patients with suspected or confirmed history of alcohol dependence or drug abuse. Patients who have participated in other clinical trials within 30 days prior to screening. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the frequency of angina attacks from baseline at Week 12 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Usage and reduction/cessation rate of nitroglycerin tablets;Changes in 24-hour Holter monitoring parameters from baseline after 12 weeks of treatment;Changes in the frequency of angina attacks from baseline during Weeks 1–11 of treatment.;Incidence of Cardiovascular Events;Changes SAQ scores from baseline at Weeks 4 8 and 12 of treatment;Changes in angina symptom scores from baseline at Weeks 4 8 and 12 of treatment.;Changes in ECG stress test parameters (Bruce protocol) from baseline after 12 weeks of treatment;Traditional Chinese medicine syndrome efficacy at Weeks 4 8 and 12 of treatment.; | — |
Countries
China
Contacts
Public ContactXU HAO
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed