key: cord-0821349-y2cr937o authors: Luo, Hui; Yang, Ming; Tang, Qiao-Ling; Hu, Xiao-Yang; Willcox, Merlin L.; Liu, Jian-Ping title: Characteristics of registered clinical trials on traditional Chinese medicine for coronavirus disease 2019 (COVID-19): a scoping review date: 2020-11-12 journal: Eur J Integr Med DOI: 10.1016/j.eujim.2020.101251 sha: 1d9bc5a43bf555ff955bb32e9d8d4a9b402177f9 doc_id: 821349 cord_uid: y2cr937o INTRODUCTION: Traditional Chinese medicine (TCM) has been fully committed to treat coronavirus disease 2019 (COVID-19) in China. An increasing number of clinical trials have been registered to evaluate the effects of TCM for COVID-19. The aim of this study was to review the existing TCM clinical trial registrations and identify potentially promising and available TCM therapies, in order to provide a reference for the global management of COVID-19. METHODS: All clinical trials on TCM for COVID-19 registered in registry platforms worldwide were searched. The data of registration temporal trend, design, objective, interventions, and relevant information were reviewed and summarized. RESULTS: 161 TCM trials were identified from three registries (January 26 to May 14 2020). Of these, 94 (58.4%) were randomized controlled trials and 114 trials (70.8%) assessed therapeutic effects; while the remainder focused on prevention, rehabilitation, and the epidemiology of TCM syndromes. Eight trials (5.0%) had completed their recruitment. TCM interventions with potential for further evaluation in terms of prevention were moxibustion, Huoxiang Zhengqi pill and Jinye Baidu granules. For treatment of COVID-19, Qingfei Paidu decoction, Huashi Baidu decoction, Lianhua Qingwen capsules, Toujie Quwen granules and Xiyanping injection, and Xuebijing injection were to be tested for their therapeutic effects and symptoms relief. For rehabilitation, Tai Chi and Liuzijue were to be tested for improving patients’ lung function. CONCLUSION: Some potentially promising TCM interventions have been identified and deserve further evaluation to establish their evidence base, particularly on populations outside of China. The coronavirus disease 2019 (COVID-19) pandemic has become a major public health problem facing the world. As of October 20, 2020, 40,251,950 cases of confirmed infections have been reported from 212 countries, areas or territories around the world [1] . Since the outbreak in Hubei, China in January 2020, the Chinese government established a prevention and control policy involving both traditional Chinese medicine (TCM) and Western medicine (WM) [2] . Therefore, TCM has been fully involved in the management of the epidemic in China. Up to now, the National Health Commission of China has issued eight versions of guidelines for COVID-19, and TCM remedies have been included since the third version in January 23, 2020 [3] . For prevention of the epidemic, 23 out of 31 provinces (including autonomous regions, and municipalities) in mainland China had officially issued preventive programs by recommending Chinese herbal formulae [4] . According to official data released in 23 April, among the confirmed COVID-19 cases, 74,187 were given TCM, accounting for 91.5% of the total cases [5] . At present, China has achieved a staged success in the management of COVID-19 for more than 6 consecutive months. As of October 20, 2020, among the 85,715 confirmed cases in mainland China, 79,047 have been cured and discharged from hospitals, accounting for 93.6%, and 4,634 have died, accounting for 5.5% [6] . The lower number of cases and deaths of COVID-19 reported in China compared to many countries may be due to the strict implementation of public health interventions (including isolating cases, contact tracing, quarantine of exposed persons, travel restrictions, school and workplace closures, cancellation of mass gatherings, and hand washing, among others) [7] , In addition, the rapid establishment of large health-care facilities (Fangcang shelter hospitals in Wuhan) which left no patient unattended [8] , and the combination of TCM and WM are believed to have played a substantial role in prevention and treatment, and this has attracted increasing attention worldwide [2] . In order to evaluate the effectiveness and safety of specific TCM therapies such as Chinese patent medicines, formulae and non-drug therapy, many clinical trials have been registered and carried out in China since the outbreak. These studies are greatly heterogeneous in terms of interventions, design, recruiting status, feasibility, and generalizability [9] . Therefore, this study was conducted to comprehensively collect and evaluate the characteristics in terms of participants, interventions and outcomes of existing TCM registered clinical trials for COVID-19, aiming to providing a reference for the global epidemic prevention and control. All the TCM clinical trial protocols on COVID- 19 The basic characteristics of registered TCM trials were extracted, including registration identifier, date of registration, title, country and province, design, study objectives, anticipated start date, interventions and control, population, sample size, outcomes and recruiting status. The overall status of registered TCM trials on COVID-19 was reviewed and collated. The study progress or results were extracted from the documentation where possible. Trials with an appropriate design and with a potential global application were screened and data were extracted and summarized. The inclusion criteria for trials were defined as follows: (1) (3) interventions having the possibility of being available and applicable globally. The extraction and assessment of data characteristics were due on July 31, 2020. [11] . (3) Jinye Baidu granules (JYBD) were officially recommended for preventing COVID-19 in some provinces of China [4] . JYBD was developed by Tongji hospital, Huazhong University of Science and Technology, and had been used for preventing SARS in Tongji Hospital in 2003 [12] . Some experimental and clinical studies found that JYBD had an antiviral effect [13] [14] [15] . The details of the above interventions and trials are shown in Table 2 . [24] . The details of the above interventions and trials are shown in Table 3 . From the number of registered clinical trials, both TCM and western medicine responded quickly to the COVID-19 pandemic during the early months in China. From the outbreak in January to basic control in March, China encouraged the application of TCM in the prevention and treatment of epidemics, based on the historical and contemporary experience from SARS and H1N1 influenza [4, 28, 29] . In response to the new communicable disease like COVID-19, doctors and TCM practitioners used the existing Chinese patent medicines or Chinese herbal-derived injections which were previously designed for other virus infections such as SARS and H1N1 influenza, which have been tested for effectiveness and safety [30] , and also developed and applied new herbal formulae in clinical practice (Table 3) . Therefore, a series of clinical studies were registered and conducted to evaluate the efficacy and safety of these interventions [9, 31] . This study systematically reviewed Regarding the specific TCM therapies for the prevention, treatment and rehabilitation of COVID-19, the following could be recommended for further evaluation and application worldwide. For prevention on high-risk population or suspected cases, moxibustion, Huoxiang Zhengqi oral liquid, and Jinye Baidu granules could be considered ( Of the 161 registered TCM trials for COVID-19, only a few will be able to complete due to lack of resources. The interventions involved in these possibly promising studies include some specific CHM formulae, Chinese patent medicines, herbal-derived injections and non-drug therapies which may have the potential feasibility of being evaluated internationally so that the evidence base for their use can be established for the management of COVID-19 pandemic. None. Supported by the National Natural Science Foundation of China (No. 81730112 and No. 81704197). 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Data and any supplementary material related to this article can be obtained from the corresponding author on request.