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Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (1): 148-153.DOI: 10.19852/j.cnki.jtcm.2022.01.010

• Review • Previous Articles    

Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review

Jingjing WEI1,2,3, Rongjuan GUO4, Guojing FU3, Xiao LIANG3, Zhenmin XU1, Min JIA3, Zixiu ZENG1, Wanqing DU1, Weiwei JIAO3, Linjuan SUN3, Hongmei LIU3, Chunli GUO3, Chenguang TONG3, Yunling ZHANG3(), Xing LIAO2()   

  1. 1 Graduate school, Beijing University of Chinese Medicine, Beijing 10029, China
    2 Center for Evidence Based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
    3 Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
    4 Department of Neurology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
  • Received:2021-02-12 Accepted:2021-05-13 Online:2022-02-15 Published:2022-01-25
  • Contact: Yunling ZHANG,Xing LIAO
  • About author:Prof. LIAO Xing, Center for Evidence Based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. Email: okfrom2008@hotmail.com.
    Prof. ZHANG Yunling, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China. yunlingzhang2004@126.com;
  • Supported by:
    NATCM TCM Inheritance and Innovation Hundred-Thousand-Ten Thousand “Talents Project QiHuang Scholar) – National TCM Leading Personnel Support Program (NATCM Personnel and Education Department [2018] No. 12)”;Research on optimizing construction of evidence-based ability of traditional Chinese medicine encephalopathy, Special fund for basic scientific research business expenses of central public welfare scientific research institutes(ZZ13-024-3)

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Abstract:

OBJECTIVE: To analyze the current status of clinical trial registration of Traditional Chinese Medicine (TCM) for the treatment of neurological diseases.

METHODS: Interventional clinical trials of TCM treatment for ischemic stroke, hemorrhagic stroke, vascular cognitive impairment, tension-type headache before September 22, 2020 on the platform of Chinese Clinical Trial Registry (ChiCTR), and ClinicalTrials.gov were searched. Two researchers independently selected the literature and extracted data.

RESULTS: A total of 180 interventional clinical trials were included for analysis. Out of 180 trials, 127 were from ChiCTR and 53 from ClinicalTrials.gov. The countries primary sponsoring the included trials were China (176, 97.8%), and the common categories of primary sponsors were hospital (131, 72.8%). Among the study design, the largest proportion of allocation was randomized (172, 95.6%), interventional model assignment was parallel (163, 90.6%), masking was double blind 49 (27.2%), and the sample size was ≤ 400 (144, 80.0%). The trials were most carried out at a single center (102, 56.7%). Among the included studies, 112 (62.2%) registered on ChiCTR attached the ethical approval documents. In terms of trial stages, 50 (27.7%) studies were in phase Ⅳ. The mostly used intervention was Chinese herbal medicines (99, 55%), acupuncture (68, 37.8%) was the second. By searching the registration number on China National Knowledge Infrastructure Database and PubMed, 38 (21.1%) registered trials were published, including 25 protocol studies and 14 research results with one (NCT02275949) published both the protocol and the results.

CONCLUSIONS: Irregular and inadequate reporting, untimely update and publication, insufficient information on traditional medicine unique characteristics, and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases. More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.

Key words: medicine, Chinese traditional, ischemic stroke, cognitive dysfunction, tension-type headache, hemorrhagic stroke, Chinese Clinical Trial Registry, ClinicalTrials.gov, critical appraisal

Cite this article

Jingjing WEI, Rongjuan GUO, Guojing FU, Xiao LIANG, Zhenmin XU, Min JIA, Zixiu ZENG, Wanqing DU, Weiwei JIAO, Linjuan SUN, Hongmei LIU, Chunli GUO, Chenguang TONG, Yunling ZHANG, Xing LIAO. Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review[J]. Journal of Traditional Chinese Medicine, 2022, 42(1): 148-153.