主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

JOURNAL OF BEIJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE ›› 2020, Vol. 43 ›› Issue (5): 368-372.doi: 10.3969/j.issn.1006-2157.2020.05.003

• COVID 2019 Forum • Previous Articles     Next Articles

Commentary on the study designs of clinical trials using traditional Chinese medicine in the treatment of COVID-19: problems and suggestions*

Wang Yuguang1, Cheng Jinlian1, Yan Shiyan2#   

  1. 1. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University,Beijing 100010, China;
    2. Institute of clinical basic medicine, Chinese Academy of Medical Sciences, Beijing 100700,China
  • Received:2020-03-02 Published:2020-06-08
  • Contact: A/Prof. Yan shiyan. Address: Institute of clinical basic medicine of traditional Chinese medicine, Chinese Academy of Sciences,Beijing 100700,China. E-mail: yanshiyan0927@sina.com
  • Supported by:
    General Projectof National Natural Science Foundation of China (NSFC) (No.81973713); National “13thfive year” Major New Drug InnovationProject (No.2019zx09734001); Special Project of “Dengfeng” of Beijing Municipal Hospital Administration (No.DFL20150902)

Abstract: There has been no specific treatment for coronavirus disease 2019 (COVID-19). Quite a number of ongoing clinical trials are conducted to search for efficacious medicine against COVID-19. Meanwhile there are concerns about study design rigor,non-specific target and adequate oversight of these trials.This paper analyzed the problems observed in current COVID-19 clinical trials investigating the efficacy of traditional Chinese medicine (TCM) therapies and then offered suggestions for possible solutions. Design of COVID-19 clinical trials should be based on the nature of COVID-19 as an emergent and acute epidemic disease.Investigators should discern the TCM understanding of COVID-19 in terms of its pathogenic factors and mechanism, combining the stage characteristics of the course of acute infectious diseases, while following TCM general understanding of pestilential diseases. Multiple clinical study designs could be employed for different objective set at different stage of epidemic disease, including epidemiological study of TCM patterns, observational study, randomized controlled trials and case studies, etc. TCM should be properly positioned in playing its effective role in intervention with severe and critical cases and not limited to mild or common types only. Meanwhile, surveillance with unified deployment needs to be in place to ensure strong ethical grounds and rigorous scientific research attitude.

Key words: COVID-19, clinical trial, traditional Chinese medicine

CLC Number: 

  • R285.6