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Study protocol
xiao jin
Guangzhou University of Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4676-1062
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Coronary artery disease (CAD) is one of the most common types of the cardiovascular diseases, previous pilot trials suggested that Traditional Chinese Medicine brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease.
Patients and Methods
This randomized controlled trial recruited 194 patients who were diagnosed CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque. The included participants were randomly assigned to the case group and control group with 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), 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 at6th month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM syndrome questionnaire scores at 0th, 3rd, and 6th months.
Discussion
This clinical trial may provide a reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque.
Keywords
Coronary artery disease, traditional Chinese herbal, randomized controlled trial, intermediate coronary lesions
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 05 Aug, 2019
Editor assigned
On 31 Jul, 2019
Submission checks complete
On 30 Jul, 2019
Version 3
Posted 19 Jun, 2019
No comments provided
Editorial decision: Minor revision
On 17 Jul, 2019
Review #1 received
Received 16 Jul, 2019
Reviewer #1 agreed
On 30 Jun, 2019
Reviewers invited
Invitations sent on 20 Jun, 2019
Submission checks complete
On 19 Jun, 2019
Editor assigned
On 19 Jun, 2019
No comments provided
Editorial decision: Minor revision
On 14 Jun, 2019
Submission checks complete
On 12 Jun, 2019
Editor assigned
On 12 Jun, 2019
No comments provided
Editorial decision: Major revision
On 19 May, 2019
Review #1 received
Received 16 May, 2019
Reviewer #1 agreed
On 07 May, 2019
Reviewers invited
Invitations sent on 04 Apr, 2019
Editor assigned
On 01 Apr, 2019
First submitted
On 21 Feb, 2019
Submission checks complete
On 21 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
xiao jin
Guangzhou University of Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4676-1062
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 05 Aug, 2019
Editor assigned
On 31 Jul, 2019
Submission checks complete
On 30 Jul, 2019
Version 3
Posted 19 Jun, 2019
No comments provided
Editorial decision: Minor revision
On 17 Jul, 2019
Review #1 received
Received 16 Jul, 2019
Reviewer #1 agreed
On 30 Jun, 2019
Reviewers invited
Invitations sent on 20 Jun, 2019
Submission checks complete
On 19 Jun, 2019
Editor assigned
On 19 Jun, 2019
No comments provided
Editorial decision: Minor revision
On 14 Jun, 2019
Submission checks complete
On 12 Jun, 2019
Editor assigned
On 12 Jun, 2019
No comments provided
Editorial decision: Major revision
On 19 May, 2019
Review #1 received
Received 16 May, 2019
Reviewer #1 agreed
On 07 May, 2019
Reviewers invited
Invitations sent on 04 Apr, 2019
Editor assigned
On 01 Apr, 2019
First submitted
On 21 Feb, 2019
Submission checks complete
On 21 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background
Coronary artery disease (CAD) is one of the most common types of the cardiovascular diseases, previous pilot trials suggested that Traditional Chinese Medicine brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules for treatment of patients with coronary artery disease.
Patients and Methods
This randomized controlled trial recruited 194 patients who were diagnosed CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque. The included participants were randomly assigned to the case group and control group with 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), 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 at6th month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM syndrome questionnaire scores at 0th, 3rd, and 6th months.
Discussion
This clinical trial may provide a reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD by clinical manifestations and examinations, in which coronary computed tomography angiography (CCTA) showed 50-70% of stenosis, with soft or mixed plaque.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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