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Published in: Trials 1/2019

Open Access 01-12-2019 | Arterial Diseases | Study protocol

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: Xiao Jin, Biqi Pan, Huanlin Wu, Bingxin Wu, Yukai Li, Xia Wang, Guoqing Liu, Xiaojing Dang, Danping Xu

Published in: Trials | Issue 1/2019

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Abstract

Background

Coronary 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.

Methods

This 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.

Discussion

This 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 registration

ClinicalTrials.gov, ID: ChiCTR1900020501​. The trial was registered on 25 December 2018.
Appendix
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Metadata
Title
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
Xiao Jin
Biqi Pan
Huanlin Wu
Bingxin Wu
Yukai Li
Xia Wang
Guoqing Liu
Xiaojing Dang
Danping Xu
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3629-4

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