STUDY PROTOCOL article
Front. Cardiovasc. Med.
Sec. Coronary Artery Disease
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1512385
Qu-shi-hua-tan Decoction's Efficacy and Safety for Patients with Angina following Coronary Revascularization: A Randomized, Doubleblind, Placebo-controlled Trial Study Protocol
Provisionally accepted
- The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China
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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 12week 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).
Keywords: protocol, randomized controlled trial, Traditional Chinese Medicine, coronary heart disease, qu-shi-hua-tan decoction
Received: 06 Nov 2024; Accepted: 17 Apr 2025.
Copyright: © 2025 Xu, Wen, Li, Li, Zhang and Lu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yan Zhang, The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510170, China
Weihui Lu, The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510170, China
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