Rationale and design of aromatic and warming-up management in coronary microvascular disease (AWARD): A study protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial

Abstract

Introduction

Current treatments for coronary microvascular disease (CMVD) have limited efficacy. Kuanxiong Aerosol (KXA), a representative preparation used for aromatic and warming-up management, is a typical Chinese proprietary medicine that relieves the symptoms of angina pectoris and contributes to improving coronary microcirculation disorders, which may provide an option for the treatment of CMVD.

Methods

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 120 eligible patients will be randomized 1:1 to KXA or placebo groups and receive 30-day interventions and follow-up. The primary outcome will be the Seattle Angina Scale score. Secondary outcomes will be the TCM (traditional Chinese medicine) syndrome score, self-rated anxiety scale score, self-rated depression scale, microcirculation function, and laboratory index for coronary microvascular.

Discussion

This trial will evaluate the clinical efficacy and safety of KXA in the treatment of CMVD. The results of this study may provide clinical evidence for the use of Chinese patent medicine in CMVD.

Trial registration

Chinese Clinical Trial Registry ChiCTR2200057494