A randomized, double-blind, controlled clinical study on the effectiveness and safety of Gualou Guanxin Mixture in the treatment of coronary heart disease angina pectoris (qi deficiency and blood stasis syndrome)

Phase 1

Conditions: Coronary heart disease angina pectoris

Registration Number: ITMCTR2000003759

Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Those who meet the diagnostic criteria for coronary heart disease and angina;
2) Those who meet the diagnostic criteria for stable fatigue-type angina;
3) Those who meet the grades I and II of fatigued angina;
4) Those who meet the diagnostic criteria of Qi deficiency and blood stasis syndrome in TCM;
5) The electrocardiogram has obvious ischemic changes (ordinary electrocardiogram ST segment level down >= 1.0mm, or/and R wave-based lead T wave inversion >= 2.0mm);
6) The electrocardiogram has ischemic changes, but does not meet the above-mentioned standard 5, and the result of exercise electrocardiogram is positive, or it is confirmed by one of the three methods of coronary angiography, radionuclide myocardial scan, and 64-slice CT Coronary artery stenosis;
7) Those who have had angina pectoris more than 2 times a week;
8) 8 points <= angina pectoris starting score <= 12 points and TCM syndrome starting score >= 8 points;
9) Between the ages of 35 and 65, there is no restriction on men and women;
10) According to GCP regulations, obtain informed consent and take the test voluntarily.

Exclusion Criteria

1) Those who are confirmed to have chest pain caused by coronary heart disease, acute myocardial infarction, other heart diseases, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, gastric and esophageal reflux, etc.;
2) Those who have undergone coronary revascularization within half a year;
3) Combined with severe hypertension (systolic blood pressure >= 180mmHg, diastolic blood pressure >= 110mmHg), severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), liver, kidney, hematopoietic system, etc. Primary diseases, mental patients;
4) Pregnant, lactating women or women with pregnancy intentions;
5) People with allergies and allergies to this medicine;
6) Have a history of drug abuse;
7) Those who are participating in other drug clinical trials.