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

Abstract 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...

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Autores principales:	Pan-pan Tian, Qing-juan Wu, Jun Li, Heng-wen Chen, Ji Wu, Ya-wen Deng, Zi-cong Xie, Wei Zhao, Yu-qing Tan
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Coronary heart disease Unstable angina pectoris Wen Xin decoction Chinese herb medicine Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/d00877f3e10542eb8928b7c276416bd5
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spelling	oai:doaj.org-article:d00877f3e10542eb8928b7c276416bd52021-11-14T12:31:10ZEfficacy 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 trial10.1186/s13063-021-05771-y1745-6215https://doaj.org/article/d00877f3e10542eb8928b7c276416bd52021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05771-yhttps://doaj.org/toc/1745-6215Abstract 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.gov NCT04661709 . Registered on 30 November 2020Pan-pan TianQing-juan WuJun LiHeng-wen ChenJi WuYa-wen DengZi-cong XieWei ZhaoYu-qing TanBMCarticleCoronary heart diseaseUnstable angina pectorisWen Xin decoctionChinese herb medicineRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Coronary heart disease Unstable angina pectoris Wen Xin decoction Chinese herb medicine Randomized controlled trial Medicine (General) R5-920
spellingShingle	Coronary heart disease Unstable angina pectoris Wen Xin decoction Chinese herb medicine Randomized controlled trial Medicine (General) R5-920 Pan-pan Tian Qing-juan Wu Jun Li Heng-wen Chen Ji Wu Ya-wen Deng Zi-cong Xie Wei Zhao Yu-qing Tan 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
description	Abstract 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.gov NCT04661709 . Registered on 30 November 2020
format	article
author	Pan-pan Tian Qing-juan Wu Jun Li Heng-wen Chen Ji Wu Ya-wen Deng Zi-cong Xie Wei Zhao Yu-qing Tan
author_facet	Pan-pan Tian Qing-juan Wu Jun Li Heng-wen Chen Ji Wu Ya-wen Deng Zi-cong Xie Wei Zhao Yu-qing Tan
author_sort	Pan-pan Tian
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_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_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_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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/d00877f3e10542eb8928b7c276416bd5
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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

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