To analyze the characteristics and trends of traditional Chinese medicine (TCM) clinical trials registered in China from 2013 to 2024, and to provide a reference for the development of new TCM drugs and clinical research strategies.

All TCM clinical trials registered on the National Medical Products Administration Drug Clinical Trial Registration and Information Disclosure Platform from its inception to December 31, 2024, were retrieved. A descriptive statistical analysis was conducted from multiple dimensions, including the number of trials, phases, design types, drug dosage forms, indications (classified using ICD-11 codes), and leading institutions.

A total of 1 125 TCM clinical trials were included, accounting for 4.03% of all registered trials during the same period. From 2013 to 2024, the annual number of registered TCM clinical trials did not show a significant growth trend, and their proportion relative to all clinical trials showed a declining trend. The trials were predominantly domestic multi-center studies (99.73%), with Phase II trials constituting the highest proportion (59.20%). A randomized, double-blind, parallel-controlled design was used in 86.31% of the trials. The rates of data safety monitoring committee establishment (3.64%) and subject insurance coverage (32.09%) were low. Oral dosage forms (capsules, granules, tablets, etc.) were the most common (85.87%). Indications were concentrated in respiratory system diseases (21.69%), digestive system diseases (15.64%), and urogenital system diseases (13.51%). The geographical distribution of leading institutions was highly concentrated, with Beijing, Tianjin, and Shanghai collectively accounting for 55.64% of the total.

While progress has been made in the standardization of TCM clinical trial design in China, overall development remains slow, with challenges including low international participation, insufficient subject protection measures, and imbalanced distribution across research areas and regions. It is recommended to introduce targeted incentive policies, encourage exploration of innovative formulations and difficult-to-treat diseases, strengthen subject rights protection, and promote the high-quality and sustainable development of TCM.