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Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (4): 604-610.DOI: 10.19852/j.cnki.jtcm.20220617.003

• Research Articles • Previous Articles     Next Articles

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

ZHOU Ziyi1,2, WAN Can2, ZHAO Yuanqi2, LIU Xiangzhe3, GAO Ying, AN Hongwei5, LI Lejun6, ZHANG Huili7, YU Xiaofei8, ZHANG Xinchun2, WANG Huijuan9, SHI Qing10, WEI Chunhua11, CHEN Jie12, HUANG Wenguo13, CHEN Junbin14, GAO Ying4,15, HU Mingzhe(), CAI Yefeng2()   

  1. 1 Department of Neurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
    2 The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510120, China
    3 Department of Neurology, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China
    4 Department of Neurology, Shenyang Second Hospital of Traditional Chinese Medicine, Shenyang 110100, China
    5 Department of Neurology, Liuzhou Traditional Chinese Medical Hospital, Liuzhou 545001, China
    6 Department of Neurology, Wuxi Traditional Chinese Medicine Hospital, Wuxi 214071, China
    7 Department of Neurology, Qinhuangdao City Hospital of Traditional Chinese Medicine, Qinhuangdao 066000, China
    8 Department of Neurology, Shanghai Shuguang Hospital, Shanghai 200120, China
    9 Department of Neurology, the Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
    10 Department of Neurology, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Jiangmen 529000, China
    11 Department of Neurology, Nanshi Hospital Affiliated to Henan University, Nanyang 473065, China
    12 Department of Neurology, Shanxi Province Hospital of Traditional Chinese Medicine, Xi'an 710003, China
    13 Department of Neurology, Maoming Hospital of Traditional Chinese Medicine, Maoming 525000, China
    14 Department of Neurology, the Northern Guangdong People's Hospital, Shaoguan 512025, China
    15 Department of Neurology and Stroke Center, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2021-04-19 Accepted:2021-07-20 Online:2022-08-15 Published:2022-07-12
  • Contact: HU Mingzhe,CAI Yefeng
  • About author:Dr. HU Mingzhe, Department of Neurology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, China. hu_mingzhe@126.com, Telephone: +86-20-81887233
    Prof. CAI Yefeng, Department of Neurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China; Guangdong Provincial Key Laboratory of Research on Emergency in TCM, Guangzhou 510120, China. caiyefeng@126.com.
  • Supported by:
    National Key Research and Development Program of China (Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke)(2018YFC1705002)

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Abstract:

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 window. METHODS: In this randomized, multicenter, double-blinded, placebo-controlled trial, 500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+ TQABC group or control group. In addition to guideline-based 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 consecutively. The 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 randomization. The 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 complications. Safety assessment will include the physical examination, laboratory detection, any adverse events or serious adverse events, and the proportion of any complications during hospitalization. DISCUSSION: 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.

Key words: stroke, clearing heat and eliminating phlegm, tonifying Qi and activating blood circulation, randomized controlled trial, clinical protocols

Cite this article

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. 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[J]. Journal of Traditional Chinese Medicine, 2022, 42(4): 604-610.