Trials | |
Efficacy and safety of Qi-Jing Hui-Xin Decoction in the treatment of coronary microvascular angina: study protocol for a randomized, controlled, multi-center clinical trial | |
Ying Li1  Zixiu Zhang2  Jun Chen2  Meijun Jia3  Meixian Jiang3  Li Huo4  Chengxin Huang4  Xiaofen Ruan4  Yuanlong Sun5  | |
[1] Cardiovascular Department, Shanghai Jing’an District Chinese Medicine Hospital, 200071, Shanghai, China;Cardiovascular Department, Shanghai Yangpu Hospital of TCM, 200090, Shanghai, China;Cardiovascular Department, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, No. 528 Zhangheng Road, Pudong New Area, 201203, Shanghai, China;Cardiovascular Department, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, No. 528 Zhangheng Road, Pudong New Area, 201203, Shanghai, China;Cardiovascular Research Institute of Traditional Chinese Medicine, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, 201203, Shanghai, China;Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, 201203, Shanghai, China; | |
关键词: Microvascular angina; Randomized controlled trial; Qi-Jing Hui-Xin Decoction; Traditional Chinese medicine; MACE; SAQ; | |
DOI : 10.1186/s13063-021-05508-x | |
来源: Springer | |
【 摘 要 】
BackgroundWith the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovascular events and all-cause mortality than the control population, and the search for effective treatments is of great clinical importance. Both basic and clinical studies have shown that Qi-Jing Hui-Xin Decoction (QJHX) can relieve angina symptoms and improve clinical efficacy, but there is a lack of high-quality clinical studies to provide a research basis. This article introduces the evaluation protocol of QJHX for the adjunctive treatment of MVA.Methods/designThis is a prospective randomized controlled trial. The trial will enroll 150 patients with MVA. On the basis of Western drug treatment, patients will be randomized into two groups, and the experimental group will receive QJHX treatment for 12 weeks and follow-up at 24 week. The primary indicators are the clinical efficacy of angina pectoris and the evidence of traditional Chinese medicine (TCM) efficacy. Secondary indicators are the Seattle Angina Scale score, serum lipid levels, electrocardiogram, and echocardiogram diagnosis. Additional indicators are endothelial function and immunoinflammatory factors. Adverse events will be monitored throughout the trial.DiscussionIntegrated traditional Chinese and Western medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of adding QJHX based on standardized Western medications. The results of the trial will provide high-level clinical research-based evidence for the application of QJHX in MVA.Trial registrationChinese Clinical Trial Registry ChiCTR1900027015. Registered on 28 October 2019.
【 授权许可】
CC BY
【 预 览 】
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RO202109177839929ZK.pdf | 926KB | download |