A randomized, double-blind, placebo-parallel controlled, multicenter clinical trial of efficacy and safety of Guhong injection in the treatment of unstable angina pectoris

Not Applicable

Recruiting

• Conditions: nstable angina

• Registration Number: ITMCTR2100004684
• Lead Sponsor: Beijing Chaoyang Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Volunteer to participate in the trial and sign the informed consent;
2. Age between 30 and 75 (including 30 and 75);
3. It meets the diagnostic criteria for unstable angina pectoris;
4. Patients with angina pectoris for at least 2 times within 10 days before enrollment;
5. Unstable angina pectoris, Braunwald grade I.

Exclusion Criteria

1. Patients who need revascularization and/or are willing to undergo revascularization as determined by the investigator;
2. Patients with resting angina pectoris 48 hours before enrollment;
3. Chest pain caused by diseases other than coronary artery disease, such as severe neurosis, hyperthyroidism, cholecardiac syndrome, gastric and esophageal reflux, aortic dissection, etc.;
4. NYHA cardiac function grade III, IV; Left ventricular ejection fraction (LVEF) < 40%; Severe arrhythmia (such as rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, II degree II type and III degree atrioventricular block) or other serious heart disease, or had a pacemaker installed within the last 3 months;
5. Severe respiratory diseases, such as respiratory failure;
6. Patients with liver, kidney, hematopoietic system and other serious diseases, including the normal upper limit of serum ALT and AST > and the normal upper limit of serum creatinine (SCR) BBB>
7. People with bleeding tendency;
8. Previous history of hemorrhagic disease, or current concurrent hemorrhagic disease;
9. Other factors affecting the evaluation of total load of ischemic myocardium, such as cardiac hypertrophy, left bundle branch block, digitalis, electrolyte disturbance, etc.;
10. Those who had taken traditional Chinese medicine for coronary heart disease or angina pectoris within 1 week before inclusion and had the effects of promoting qi, promoting blood circulation and removing blood stasis;
11. People with allergic constitution or known allergy to the test drug;
12. A history of mental illness or drug or alcohol abuse;
13. Women who are pregnant or lactating, or have a family planning plan during the study period;
14. Participating in clinical trials of other drugs within the last 3 months;
15. The investigator considers it inappropriate to participate in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of angina attacks on day 10 changed from baseline;