Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial
IntroductionThe Chinese herbal compound formula, Shenqisuxin granule (SQSX), promotes neovascularization and prevents in-stent restenosis in modern pharmaceutical studies and is expected to provide an effective strategy for non-ST-segment elevation acute coronary syndrome (NSTEACS). Thus, this study...
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| Format: | Article |
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Frontiers Media S.A.
2022-06-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.888724/full |
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| author | Xiaoping Wu Ming Guo Shihua Shi Shihua Shi Shihua Shi Shengnan Shi Yanping Deng Shenglan Wang Yabing Wang Peili Wang Keji Chen |
| author_facet | Xiaoping Wu Ming Guo Shihua Shi Shihua Shi Shihua Shi Shengnan Shi Yanping Deng Shenglan Wang Yabing Wang Peili Wang Keji Chen |
| author_sort | Xiaoping Wu |
| collection | DOAJ |
| description | IntroductionThe Chinese herbal compound formula, Shenqisuxin granule (SQSX), promotes neovascularization and prevents in-stent restenosis in modern pharmaceutical studies and is expected to provide an effective strategy for non-ST-segment elevation acute coronary syndrome (NSTEACS). Thus, this study aims to examine the efficacy and safety of SQSX for NSTEACS and initially reveal its mechanism.Methods/DesignThe study is a randomized, double-blinded and placebo-controlled trial. A total of 66 participants will be randomly allocated to one of the following two groups. Participants in the SQSX group will receive conventional treatment plus SQSX, while the placebo group will receive conventional treatment plus placebo, both for 14 days. The primary outcome, hs-CRP, and secondary outcome the Seattle Angina Questionnaire (SAQ) will be assessed at baseline, 7 ± 3 days and 14 ± 3 days. At all visit windows, other indicators including creatine kinase (CK), creatine kinase-myocardial band (CK-MB), cardiac troponins I (cTnI), 12-lead electrocardiograph and the syndrome scores of Qi deficiency and blood stasis will be tested and metagenomic sequencing for intestinal flora will be performed. Echocardiography and safety assessment will be performed at baseline and 14 ± 3 days. Adverse events will be monitored during the trial.DiscussionThe purpose of the study is to examine the efficacy and safety of SQSX to improve NSTEACS and initially reveal its mechanism.Trial RegistrationChina Clinical Trial Registry, ChiCTR2000029226. Registered on January 19, 2020. |
| first_indexed | 2024-12-11T16:29:38Z |
| format | Article |
| id | doaj.art-17d9ba3ea6bd426d9601d613a50be781 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-12-11T16:29:38Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-17d9ba3ea6bd426d9601d613a50be7812022-12-22T00:58:38ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-06-01910.3389/fcvm.2022.888724888724Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled TrialXiaoping Wu0Ming Guo1Shihua Shi2Shihua Shi3Shihua Shi4Shengnan Shi5Yanping Deng6Shenglan Wang7Yabing Wang8Peili Wang9Keji Chen10National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Geriatric, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, SwitzerlandFaculty of Science, University of Basel, Basel, SwitzerlandNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Psychiatry and Medical Genetics, University of Alberta, Edmonton, AB, CanadaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaIntroductionThe Chinese herbal compound formula, Shenqisuxin granule (SQSX), promotes neovascularization and prevents in-stent restenosis in modern pharmaceutical studies and is expected to provide an effective strategy for non-ST-segment elevation acute coronary syndrome (NSTEACS). Thus, this study aims to examine the efficacy and safety of SQSX for NSTEACS and initially reveal its mechanism.Methods/DesignThe study is a randomized, double-blinded and placebo-controlled trial. A total of 66 participants will be randomly allocated to one of the following two groups. Participants in the SQSX group will receive conventional treatment plus SQSX, while the placebo group will receive conventional treatment plus placebo, both for 14 days. The primary outcome, hs-CRP, and secondary outcome the Seattle Angina Questionnaire (SAQ) will be assessed at baseline, 7 ± 3 days and 14 ± 3 days. At all visit windows, other indicators including creatine kinase (CK), creatine kinase-myocardial band (CK-MB), cardiac troponins I (cTnI), 12-lead electrocardiograph and the syndrome scores of Qi deficiency and blood stasis will be tested and metagenomic sequencing for intestinal flora will be performed. Echocardiography and safety assessment will be performed at baseline and 14 ± 3 days. Adverse events will be monitored during the trial.DiscussionThe purpose of the study is to examine the efficacy and safety of SQSX to improve NSTEACS and initially reveal its mechanism.Trial RegistrationChina Clinical Trial Registry, ChiCTR2000029226. Registered on January 19, 2020.https://www.frontiersin.org/articles/10.3389/fcvm.2022.888724/fullShenqisuxin granulenon-ST-segment elevation acute coronary syndromeintestinal florarandomized controlled trialChinese herbs |
| spellingShingle | Xiaoping Wu Ming Guo Shihua Shi Shihua Shi Shihua Shi Shengnan Shi Yanping Deng Shenglan Wang Yabing Wang Peili Wang Keji Chen Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial Frontiers in Cardiovascular Medicine Shenqisuxin granule non-ST-segment elevation acute coronary syndrome intestinal flora randomized controlled trial Chinese herbs |
| title | Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial |
| title_full | Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial |
| title_fullStr | Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial |
| title_full_unstemmed | Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial |
| title_short | Efficacy and Safety of Shenqisuxin Granule for Non-ST-segment Elevation Acute Coronary Syndrome: Study Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial |
| title_sort | efficacy and safety of shenqisuxin granule for non st segment elevation acute coronary syndrome study protocol for a randomized double blinded placebo controlled trial |
| topic | Shenqisuxin granule non-ST-segment elevation acute coronary syndrome intestinal flora randomized controlled trial Chinese herbs |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.888724/full |
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