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.
journal_name
Trialsjournal_title
Trialsauthors
Jin X,Pan B,Wu H,Wu B,Li Y,Wang X,Liu G,Dang X,Xu Ddoi
10.1186/s13063-019-3629-4subject
Has Abstractpub_date
2019-08-20 00:00:00pages
520issue
1issn
1745-6215pii
10.1186/s13063-019-3629-4journal_volume
20pub_type
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