Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol.

INTRODUCTION

The Qu-shi-hua-tan decoction (QSHTD), formulated by academician Chen Keji, is an empirical decoction for coronary heart disease (CHD). We conducted a randomized controlled trial to assess the effectiveness and safety of QSHTD in managing angina after coronary revascularization (AACR) in CHD patients.

METHODS AND DESIGN

This double-blind randomized controlled trial will be conducted at Guangdong Provincial Hospital of Traditional Chinese Medicine. We will allocate 98 qualified participants to either the experimental or control group in a 1:1 ratio through random selection. The experimental group will be given standard care along with QSHTD, whereas the control group will receive standard care and a placebo. The study will span 26 weeks, consisting of a 2-week initial phase, a 12-week intervention phase, and a 12-week monitoring phase. The main outcome measure will be myocardial blood flow (MBF) assessed using adenosine stress real-time myocardial perfusion echocardiography (RTMPE). The secondary outcomes will be Canadian Cardiovascular Sociation Classification, Seattle Angina Questionnaire, Traditional Chinese Medicine (TCM) symptom evaluation; and major adverse cardiac events (MACE).

DISCUSSION

This study seeks to deliver compelling proof of the superior methodological and reporting standards of QSHTD's effectiveness and safety within AACR treatment.

CLINICAL TRIAL REGISTRATION

Chinese Clinical Trial Registration Center [www.chictr.org.cn]. The trial was registered on November 26, 2020 [ChiCTR2000040270].