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Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying qi and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

引用

Journal of Traditional Chinese Medicine 2022年第4期42卷 604-610页

作者： ZHOU Ziyi WAN Can ZHAO Yuanqi LIU Xiangzhe GAO Ying AN Hongwei LI Lejun ZHANG Huili YU Xiaofei ZHANG Xinchun WANG Huijuan SHI qing WEI Chunhua CHEN Jie HUANG Wenguo CHEN Junbin GAO Ying HU Mingzhe CAI Yefeng Department of Neurology Guangdong Provincial Hospital of Chinese MedicineGuangzhou 510120China the Second Clinical College of Guangzhou University of Chinese Medicine Guangzhou 510120China Department of Neurology The First Affiliated Hospital of Henan University of Traditional Chinese MedicineZhengzhou 450000China Department of Neurology Shenyang Second Hospital of Traditional Chinese MedicineShenyang 110100China Department of Neurology Liuzhou Traditional Chinese Medical HospitalLiuzhou 545001China Department of Neurology Wuxi Traditional Chinese Medicine HospitalWuxi 214071China Department of Neurology Qinhuangdao City Hospital of Traditional Chinese MedicineQinhuangdao 066000China Department of Neurology Shanghai Shuguang HospitalShanghai 200120China Department of Neurology the Second Hospital of Hebei Medical UniversityShijiazhuang 050000China Department of Neurology Jiangmen Wuyi Hospital of Traditional Chinese MedicineJiangmen 529000China Department of Neurology Nanshi Hospital Affiliated to Henan UniversityNanyang 473065China Department of Neurology Shanxi Province Hospital of Traditional Chinese MedicineXi'an 710003China Department of Neurology Maoming Hospital of Traditional Chinese MedicineMaoming 525000China Department of Neurology the Northern Guangdong People's HospitalShaoguan 512025China Department of Neurology and Stroke Center Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineBeijing 100700China

OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time ***:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control *** addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo *** primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after *** secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital *** assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during ***:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.

关键词： stroke clearing heat and eliminating phlegm tonifying qi and activating blood circulation randomized controlled trial clinical protocols

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