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)

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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003759

Enrollment

Unknown

Registered

2020-08-27

Start date

2021-01-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary heart disease angina pectoris

Interventions

Placebo group:Gualou Guanxin Mixture Simulator

Trial group:Gualou Guanxin Mixture

Eligibility

Sex/Gender

All

Inclusion criteria

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 = 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

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.

Design outcomes

Primary

Measure	Time frame
Angina symptoms;Security parameters;Judgment of curative effect of TCM syndromes;ECG;	—

Countries

China

Contacts

Public ContactMeiping Wu

Shanghai Municipal Hospital of Traditional Chinese Medicine

meipingwu1207@hotmail.com+86 13661977245

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026