Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial
Jun Li,
Yuqing Zhang,
Chao Liu,
Yongmei Liu,
Yi Li,
Jie Wang,
Mingyan Huang,
Guang Chen,
Qingya Guan,
Qing Zhao,
Kuiwu Yao,
Zhenpeng Zhang,
Haoqiang He,
Fei Lin,
Xinhui He,
Xing-jiang Xiong,
Mei Han
Affiliations
Jun Li
2 Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University；Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
Yuqing Zhang
Department of Health Research Methods, Evidence and Impact, Mcmaster University, Hamilton, Ontario, Canada
Chao Liu
Department of Neurosurgery, Xiamen Susong Hospital, Xiamen, China
Yongmei Liu
Molecular Biology Laboratory, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Yi Li
Department of Infectious Diseases, Suining Central Hospital, Suining, China
Jie Wang
1 Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R. China
Mingyan Huang
Department of Cardiology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Guang Chen
Department of Cardiology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Qingya Guan
Graduate School, Hubei University of Chinese Medicine, Wuhan, China
Qing Zhao
Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
Kuiwu Yao
Department of Cardiology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Zhenpeng Zhang
Department of Cardiology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Haoqiang He
Department of Radiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center of Cancer Medicine, Guangzhou, Guangdong, China
Fei Lin
Department of Cardiology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China
Xinhui He
Department of Cardiology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, China
Xing-jiang Xiong
Department of Cardiology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Mei Han
2 Department of laboratory medicine, The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, China
Introduction As the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysis This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration number ChiCTR-IOR-17013189; Pre-results.
