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[Analysis on clinical study protocols of traditional Chinese medicine for coronavirus disease 2019].

作者信息

Wang Hui, Jin Xin-Yao, Pang Bo, Liu Chun-Xiang, Zheng Wen-Ke, Yang Feng-Wen, Pang Wen-Tai, Zhang Jun-Hua

机构信息

Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2020 Mar;45(6):1232-1241. doi: 10.19540/j.cnki.cjcmm.20200220.501.


DOI:10.19540/j.cnki.cjcmm.20200220.501
PMID:32281330
Abstract

To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.

摘要

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引用本文的文献

[1]
Andrographolide Sulfonates and Xiyanping: A Review of Chemical Composition, Pharmacological Activities, Clinical Applications, and Adverse Reactions.

Pharmaceuticals (Basel). 2025-1-29

[2]
Characteristics and result reporting of registered COVID-19 clinical trials of Chinese and Indian traditional medicine: A comparative analysis.

Front Med (Lausanne). 2023-2-17

[3]
PROSPERO's systematic review protocols of traditional Chinese medicine for COVID-19: An overview.

Integr Med Res. 2021

[4]
Potential Mechanisms of Action of Chinese Patent Medicines for COVID-19: A Review.

Front Pharmacol. 2021-7-15

[5]
Application of Big Data and Artificial Intelligence in COVID-19 Prevention, Diagnosis, Treatment and Management Decisions in China.

J Med Syst. 2021-7-24

[6]
Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials.

BMC Med Res Methodol. 2021-4-30

[7]
A Retrospective Study on the Use of Chinese Patent Medicine in 24 Medical Institutions for COVID-19 in China.

Front Pharmacol. 2020-11-30

[8]
Efficacy and safety of Shufeng Jiedu capsule in the treatment of COVID-19: A protocol for systematic review and meta analysis.

Medicine (Baltimore). 2020-12-11

[9]
Research Collaboration and Outcome Measures of Interventional Clinical Trial Protocols for COVID-19 in China.

Front Public Health. 2020-9-2

[10]
[A systematic pharmacological investigation of pharmacologically active ingredients in Toujie Quwen granules for treatment of COVID-19].

Nan Fang Yi Ke Da Xue Xue Bao. 2020-8-30

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