Registration status and characterization of clinical trial registries in traditional medicine_Chinese Journal of Evidence-Based Medicine

Authors：

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;

Corresponding?author：

LIANG Ning, Email: liangning229@163.com; SHI Nannan, Email: 13811839164@vip.126.com

Keywords：

Traditional medicine; Clinical trials; Clinical trial registration; Registration characteristics; International Traditional Medicine Clinical Trial Registry (ITMCTR)

DOI：

10.7507/1672-2531.202407202

Video：

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Objective To analyze the current research status, characteristics and development trends 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 analyze 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 trial sponsors of the study covered 9 countries and a total of 34 provinces/autonomous regions/municipalities in China, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total. 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. A total of 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and 213 large-sample studies with a sample size of more than 1 000 cases were included. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral prescription of herbal medicine interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule intervention 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.

Citation： 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. Registration status and characterization of clinical trial registries in traditional medicine. Chinese Journal of Evidence-Based Medicine, 2025, 25(2): 162-168. doi: 10.7507/1672-2531.202407202 Copy

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13.	ITMCTR. 基于真實世界臨床醫療大數據的注射用血栓通(凍干)CER研究. 2020.
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15.	ITMCTR. “斡旋三焦”治腎法治療慢性腎臟病臨床療效的回顧性研究. 2020.
16.	ITMCTR. 澀腸止瀉散治療兒童急性水樣便腹瀉評價其有效性和安全性的隨機、雙盲、平行對照、多中心臨床研究. 2020.
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22.	中華人民共和國中央人民政府. 關于學習貫徹習近平總書記重要指示精神進一步加強醫務人員隊伍建設的通知. 2020.
23.	趙國楨, 李慧珍, 梁寧, 等. 中醫臨床實踐指南聯合真實世界研究模式的方法學思考. 中國實驗方劑學雜志, 2024, 30(22): 87-93.
24.	王一名, 代欣玥, 郭曼萍, 等. 中醫藥真實世界研究數據轉化方法. 中國循證醫學雜志, 2023, 23(9): 1081-1088.
25.	中華人民共和國中央人民政府. 關于加強新時代少數民族醫藥工作的若干意見. 2018.
26.	沈慧青, 許鋒, 吳皓, 等. 綜合性醫院多學科交叉創新與實踐. 中國醫院, 2019, 23(6): 54-56.
27.	Liang N, Zhang Y, Zhang X, et al. International Traditional Medicine Clinical Trial Registry: a meaningful initiative and its future development. J Evid Based Med, 2024, 17(3): 486-489.

1. WHO. Integrating traditional medicine in health care. 2024.
2. 張海涵, 宋欣陽. 基于《世界衛生組織傳統和補充醫學全球報告2019》的傳統和補充醫學全球發展分析. 中華中醫藥雜志, 2020, 35(6): 3090-3093.
3. 周莉, 歐陽文偉, 李庚, 等. 中國登記研究的現狀分析. 中國循證醫學雜志, 2019, 19(6): 702-707.
4. Angelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Ugeskr Laeg, 2004, 166(38): 3283-3284.
5. ICMJE. Update on trials registration: is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. 2005.
6. WHO. Home/International Clinical Trials Registry Platform (ICTRP).
7. WHO. International Clinical Trials Registry Platform (ICTRP). Neural Regen Res, 2011, 6(20): 1580-1600.
8. 吳泰相, 李幼平, 李靜, 等. 臨床試驗的里程碑事件: 全球臨床試驗注冊制度建成運行. 中國循證醫學雜志, 2007, (7): 479-480.
9. WHO. New member of the primary registry network: International Traditional Medicine Clinical Trial Registry (ITMCTR). 2024.
10. 中華人民政府網. 我國搭建的傳統醫學臨床試驗注冊平臺獲認世衛一級注冊機構. 2023.
11. Zhang X, Liang N, Zhang Y, et a1. An introduction to International Traditional Medicine Clinical Trial Registry (ITMCTR): a cross-regional registry focusing on theme of traditional medicine. STCM, 2(3): 194-201.
12. ITMCTR. 中藥配方顆粒十萬例臨床安全性集中監測項目. 2020.
13. ITMCTR. 基于真實世界臨床醫療大數據的注射用血栓通(凍干)CER研究. 2020.
14. ITMCTR. 止血祛瘀明目片治療眼底出血上市后再評價真實世界的研究臨床試驗. 2020.
15. ITMCTR. “斡旋三焦”治腎法治療慢性腎臟病臨床療效的回顧性研究. 2020.
16. ITMCTR. 澀腸止瀉散治療兒童急性水樣便腹瀉評價其有效性和安全性的隨機、雙盲、平行對照、多中心臨床研究. 2020.
17. 陳芷涵, 梁丹, 萬李娜, 等. 中醫藥臨床研究的未來發展趨勢及思考. 中國實驗方劑學雜志, 2024, 30(22): 102-109.
18. 中華人民共和國科學技術部. 關于印發《“十四五”衛生與健康科技創新專項規劃》的通知. 2022.
19. 中華人民政府網. 中共中央國務院關于促進中醫藥傳承創新發展的意見. 2019.
20. 中華人民共和國中央人民政府. 科技部印發《關于加強科技創新促進新時代西部大開發形成新格局的實施意見》的通知. 2020.
21. 鄧明卓, 周春蓮, 陳惠清. 醫院感染管理相關科研現狀調查及發展趨勢. 中國感染控制雜志, 2016, 15(9): 686-688.
22. 中華人民共和國中央人民政府. 關于學習貫徹習近平總書記重要指示精神進一步加強醫務人員隊伍建設的通知. 2020.
23. 趙國楨, 李慧珍, 梁寧, 等. 中醫臨床實踐指南聯合真實世界研究模式的方法學思考. 中國實驗方劑學雜志, 2024, 30(22): 87-93.
24. 王一名, 代欣玥, 郭曼萍, 等. 中醫藥真實世界研究數據轉化方法. 中國循證醫學雜志, 2023, 23(9): 1081-1088.
25. 中華人民共和國中央人民政府. 關于加強新時代少數民族醫藥工作的若干意見. 2018.
26. 沈慧青, 許鋒, 吳皓, 等. 綜合性醫院多學科交叉創新與實踐. 中國醫院, 2019, 23(6): 54-56.
27. Liang N, Zhang Y, Zhang X, et al. International Traditional Medicine Clinical Trial Registry: a meaningful initiative and its future development. J Evid Based Med, 2024, 17(3): 486-489.

Chinese Journal of Evidence-Based Medicine

Registration status and characterization of clinical trial registries in traditional medicine

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