ZHANG Yujing , ZHANG Xuefei , YAN Lijiao , ZHAO Chen , YANG Sihong , HU Ziteng , YE Zehui , LI Huizhen , ZHANG Haili , CHE Qianzi , CHEN Zhao , LIANG Ning , SHI Nannan , WANG Yanping
  • Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
LIANG Ning, Email: liangning229@163.com; SHI Nannan, Email: 13811839164@vip.126.com
Traditional medicine; Clinical trials; Clinical trial registration; Registration characteristics; International Traditional Medicine Clinical Trial Registry (ITMCTR)
10.7507/1672-2531.202407202
Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables References Cited by

Objective  To analyze the current research status, characteristics and development trend of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods  The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyzed in terms of the basic information of the trials, the diseases studied and the interventions. Results  A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The studies conducted covered a total of 47 countries/regions, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total, and included 13 overseas regions. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and there were 213 large-sample studies with a sample size of more than 1 000 cases. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral herbal soup/granule interventions. Conclusion  Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule interventional studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.