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

Efficacy and Safety of Chinese Herbal Medicine Wen Xin Granules for the Treatment of Unstable Angina Pectoris With Yang Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Controlled Trial

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.

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 myocardial infarction with high morbidity and mortality. Standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. However, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. Wen Xin granule, as a Chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. However, there is still insufficient evidence on his specific efficacy and safety. Therefor, we'd like to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.

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.