Abstract
Background: Coronary heart disease (CHD) is a clinical syndrome caused by coronary atherosclerosis (AS) or functional changes of coronary arteries. Our previous experimental study found that the main component of Astragalus, Astragaloside IV, and the main component of Salvia Miltiorrhiza, Tanshinone IIA, can effectively improve myocardial ischemic injury. Methods: This study was a prospective, randomized, blinded, parallel design trial. A total of 160 eligible patients were randomized to a treatment group (in three groups) or the placebo control group in a 1:1:1:1 ratio using a central randomization system. Patients will receive appropriate treatment for 7 days within 24 hours after enrollment and follow-up for 28 days. Main evaluation indicators: cell count, serum high-sensitivity C-reactive protein (hs-CRP) level, monocyte chemoattractant protein 1 (MCP-1), Interleukin-6(IL-6), IL-1β, IL-8, IL-18, IL-10, Tumor necrosis factor(TNF-α), Oxidized low density lipoprotein(OX-LDL), exosome levels, and angina grade and Traditional Chinese Medicine (TCM) symptom changes scale. Secondary evaluation indicators: B-type natriuretic peptide (BNP) level, troponin (cTn), muscle enzyme isoenzyme (CK-MB), heart-type fatty acid binding protein (H-FABP), liver function, renal function, blood coagulation and the like. Adverse events will be monitored throughout the trial. Discussion: This is a randomized controlled trial of Chinese herbal extracts for the treatment of coronary heart disease. The results of this trial will provide valuable clinical evidence for the recommendations for disease management and identify its underlying mechanisms.
Effects of Astragalus injection and Salvia Miltiorrhiza injection on serum inflammatory markers in patients with stable coronary heart disease: a randomized controlled trial protocol
