AUTHOR=Xu Wenjing , Wen Jingwei , Li Xijiu , Li Xiaoqing , Zhang Yan , Lu Weihui 

TITLE=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

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 12 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1512385

DOI=10.3389/fcvm.2025.1512385

ISSN=2297-055X

ABSTRACT=IntroductionThe 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 designThis 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).DiscussionThis study seeks to deliver compelling proof of the superior methodological and reporting standards of QSHTD's effectiveness and safety within AACR treatment.
Clinical Trial RegistrationChinese Clinical Trial Registration Center [www.chictr.org.cn]. The trial was registered on November 26, 2020 [ChiCTR2000040270].