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Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

INTRODUCTION: Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the mic...

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Autores principales: Tian, Pan-pan, Wu, Qing-juan, Li, Jun, Chen, Heng-wen, Wu, Ji, Deng, Ya-wen, Xie, Zi-cong, Zhao, Wei, Tan, Yu-qing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8590352/
https://www.ncbi.nlm.nih.gov/pubmed/34774099
http://dx.doi.org/10.1186/s13063-021-05771-y
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author Tian, Pan-pan
Wu, Qing-juan
Li, Jun
Chen, Heng-wen
Wu, Ji
Deng, Ya-wen
Xie, Zi-cong
Zhao, Wei
Tan, Yu-qing
author_facet Tian, Pan-pan
Wu, Qing-juan
Li, Jun
Chen, Heng-wen
Wu, Ji
Deng, Ya-wen
Xie, Zi-cong
Zhao, Wei
Tan, Yu-qing
author_sort Tian, Pan-pan
collection PubMed
description INTRODUCTION: Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China’s medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP. METHODS AND ANALYSIS: This is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization. DISCUSSION: This trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP. TRIAL REGISTRATION: ClinicalTrials.govNCT04661709. Registered on 30 November 2020
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spelling pubmed-85903522021-11-15 Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial Tian, Pan-pan Wu, Qing-juan Li, Jun Chen, Heng-wen Wu, Ji Deng, Ya-wen Xie, Zi-cong Zhao, Wei Tan, Yu-qing Trials Study Protocol INTRODUCTION: Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China’s medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP. METHODS AND ANALYSIS: This is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization. DISCUSSION: This trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP. TRIAL REGISTRATION: ClinicalTrials.govNCT04661709. Registered on 30 November 2020 BioMed Central 2021-11-13 /pmc/articles/PMC8590352/ /pubmed/34774099 http://dx.doi.org/10.1186/s13063-021-05771-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Tian, Pan-pan
Wu, Qing-juan
Li, Jun
Chen, Heng-wen
Wu, Ji
Deng, Ya-wen
Xie, Zi-cong
Zhao, Wei
Tan, Yu-qing
Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
title Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
title_full Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
title_fullStr Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
title_full_unstemmed Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
title_short Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
title_sort efficacy and safety of chinese herbal medicine wen xin granules for the treatment of unstable angina pectoris with yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8590352/
https://www.ncbi.nlm.nih.gov/pubmed/34774099
http://dx.doi.org/10.1186/s13063-021-05771-y
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