Status:
UNKNOWN
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine
National Natural Science Foundation of China
Conditions:
Coronary Heart Disease
Unstable Angina
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
Coronary heart disease has remained the leading cause of death worldwide over the past decades. Unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT04661709
Start Date
March 1 2021
End Date
June 1 2023
Last Update
January 25 2021
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