Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05113-y.
【저자키워드】 COVID-19, SARS, Traditional Chinese medicine, Clinical trial registration, WHO Trial Registration Data Set, H1N1, 【초록키워드】 coronavirus, clinical trial, Influenza, Diagnosis, clinical trials, Traditional Chinese medicine, Intervention, severe acute respiratory syndrome Coronavirus, outcomes, Registration, clinical, H1N1, respiratory, registry, information, H1N1 influenza, patients, TCM, criteria, focus, data set, deficiency, acute respiratory syndrome, supplementary material, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, deficiencies, rationale, Chinese, Version, Chinese Clinical Trial Registry, ICTRP, description, objective, Result, lack, examined, reported, provided, searched, the WHO, 【제목키워드】 public health, Trial, Traditional Chinese medicine, Chinese,