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The efficacy and safety of Shenzhu Guanxin Recipe Granules for the treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial

Authors
  • Jin, Xiao1
  • Pan, Biqi2
  • Wu, Huanlin3
  • Wu, Bingxin1
  • Li, Yukai4
  • Wang, Xia4
  • Liu, Guoqing4
  • Dang, Xiaojing4
  • Xu, Danping4
  • 1 Guangzhou University of Chinese Medicine, Second School of Clinical Medicine, Guangzhou, China , Guangzhou (China)
  • 2 GuangDong Women and Children Hospital, Department of Traditional Chinese medicine, Guangzhou, China , Guangzhou (China)
  • 3 Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China , Beijing (China)
  • 4 Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Department of Cardiology, Guangzhou, China , Guangzhou (China)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Aug 20, 2019
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s13063-019-3629-4
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundCoronary artery disease (CAD) is one of the most common types of the cardiovascular disease. Previous pilot trials have suggested that Traditional Chinese Medicine (TCM) has brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules (SGR) for the treatment of patients with CAD.MethodsThis randomized controlled trial recruited 190 patients who were diagnosed with CAD by clinical manifestation and examination and in which coronary computed tomography angiography (CCTA) showed 50–70% stenosis, with soft or mixed plaque types. The included participants were randomly assigned to the case group and control group using a 1:1 allocation ratio; patients in the case group received SGR and usual care, and those in the control group received placebo (6 g/day for 6 months) and usual care. The endpoint of the study included Calcium Coverage Score (CCS), C-reactive protein (CRP) level, and the levels of blood lipids, tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), and ATP-binding membrane cassette transporter A1 (ABCA1) were calculated before recruiting and at the sixth month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM Syndrome Questionnaire scores at 0, 3, and 6 months.DiscussionThis clinical trial may provide reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD diagnosed by clinical manifestation and examination, in which CCTA showed 50–70% stenosis, with soft or mixed plaque types.Trial registrationClinicalTrials.gov, ID: ChiCTR1900020501. The trial was registered on 25 December 2018.

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