Efficacy and safety of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction: A single-center, double-blind, randomized controlled trial

BACKGROUND: The morbidity and mortality of acute myocardial infarction are on the rise, and the efficacy of conventional treatment is limited. Shexiang Baoxin Pill is a kind of proprietary Chinese medicine, which has been widely used in the treatment of acute myocardial infarction in China, and has certain advantages. At present, there is a lack of strict randomized controlled trials to verify the efficacy and safety of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction. Therefore, the purpose of this randomized controlled trial is to evaluate the clinical efficacy of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction. METHODS: This is a prospective randomized controlled trial to study the efficacy and safety of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction. It is approved by the Clinical Research Society of our hospital. According to 1:1, the patients will be randomly divided into observation group (Shexiang Baoxin Pill combined with Western medicine group) and control group (routine Western medicine group). The patients in the 2 groups will be treated continuously for 4 weeks and followed up for 3 months. Pay attention to its curative effect index and safety index. The observation indexes included total effective rate of improvement of cardiac function, left ventricular ejection fraction (LVEF), endothelin (ET), nitric oxide (NO) level, interleukin-6 (IL--6), adverse reactions, and so on. We will analyze the structure by SPSS version 19.0. DISCUSSION: This study will evaluate the efficacy and safety of Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction. The results of this experiment will provide clinical basis for Shexiang Baoxin Pill combined with Western medicine in the treatment of acute myocardial infarction. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/PYJTK.