Efficacy and safety of Guhong injection for treating the Coronary microvascular disease:study protocol for a randomized controlled trial

Background: Coronary microvascular disease (CMVD) refers to cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculation lesions, often presenting as angina pectoris attack. Coronary artery of microtubules dysfunction is one of the pathogenesis of coronary heart disease,but the occurrence and development and the current of CMVD intervention therapy remains to be further researched.Chinese traditional medicine (TCM)has advantages in the treatment of cardiovascular diseases, therefore, this article describes an ongoing randomized controlled clinical trial, based on the theory of TCM, for the purpose of evaluating the efficacy and safety of Guhong injection ,a Chinese patent medicine,compared with placebo in patients suffering from CMVD. Methods/design: This is a multicenter, randomized, parallel arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, with a 8-week follow-up. The primary outcome is the frequency of angina attacks, Secondary outcomes include myocardial metabolites, ecg changes, quantitative score of TCM syndromes, inflammatory response and endothelial function indicators. Discussion: This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD. Trial registration: Chinese Clinical Trials Registry, ChiCTR1900022902. Registered on 27 April 2019.