Characteristics analysis of phase Ⅱ clinical trials of new Chinese medicine from 2015 to 2024

LEI Xiang; ZHAO Chen; DAI Shun; SUN Hao; XU Ya; OU-YANG Hui-tian; GAO Chun-sheng; CHENG Jin-lian

doi:10.20251/j.cnki.1003-3734.2025.23.001

Abstract：This paper sorts out the phaseⅡclinical trials of traditional Chinese medicine registered in the drug clinical trial registration and information publicity platform of the Drug Evaluation Center of the State Drug Administration from January 1,2015 to October 1,2024,and analyzed the dosage form,indication,study design,sample size,dosage,and syndrome type,etc.A total of 393 Phase Ⅱ clinical trials involving 336 varieties were included in this study.The results showed that:granules have become the main dosage form in new drug development,followed by capsule and tablet.Three dosage forms accounted for 75.3%of the drugs.The indications included 136 diseases,with trials on the respiratory,digestive,and cardiovascular and cerebrovascular system registered the most.Most indications are represented by only one research variety each.More than 90%of the trials were randomized,double-blind,placebo-controlled designs.Dose exploration was conducted in 54.96%of the studies-primarily divided into two dosing groups-with a typical dose ratio being approximately 2∶1.The sample size of each trial ranged from 24 to 704 cases,and the average sample size of each group was 31 to 120 cases,accounting for 86.01%.Based on the analysis of the above information,this paper reviews the literature,compares the research characteristics of new Chinese medicine compound medicines approved for market from 2005 to 2021 and the review of application for registration of Chinese medicine from 2021 to 2024,and discusses the differences in research and development characteristics at different stages and the reasons,so as to provide beneficial inspiration for the research and development of new Chinese medicine medicines in the future.