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.

Abstract

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].