Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: National Natural Science Foundation of China; Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine
• Treatments: Aspirin; Atorvastatin; Clopidogrel; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Metoprolol; Nitroglycerin; Trimetazidine

Criteria

Inclusion Criteria:

• aged between 35 and 75 years of age;

• diagnosed with CAD through coronary arteriography, clinically diagnosed with UAP in low or medium risk;

• belong to Yang deficiency and blood stasis syndrome according to TCM, and give written informed consent.

• For the diagnostic criteria of UAP, the investigators will refer to 2014 AHA/ACC Guidelines for the Diagnosis and Management of Non-ST-Elevation Acute Coronary Syndromes.

• For the TCM diagnostic criteria, the investigators will refer to Guidelines for Clinical Research into New Traditional Chinese Medicine Drugs for Chest Obstruction (2002 edition).

Exclusion Criteria:

• chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia

• with New York Heart Association class III or IV heart failure, in acute phase of cerebral infarction;

• with uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg in the resting state)

• with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia;

• female patients in pregnancy or lactation;

• by participating in other clinical trials.