Analysis of clinical study registration characteristics of traditional medicine for the treatment of type 2 diabetes mellitus based on the International Clinical Trials Registry Platform  

作　　者：Sihong Yang Xinghua Xiang Jiaqi Chai Yumeng Tan Wenyuan Xu Dezhao Kong Ning Liang Lijiao Yan Huifang Zhang Tiancai Wen Hui Zhao 

机构地区：[1]Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,China [2]China Center for Evidence-Based Traditional Chinese Medicine,Beijing,China [3]Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang,China [4]Traditional Chinese Medicine Data Center,China Academy of Chinese Medical Sciences,Beijing,China [5]Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing,China

出　　处：《Guideline and Standard in Chinese Medicine》2024年第3期91-105,共15页中医规范与标准(英文)

基　　金：This work was supported by China Academy of Chinese Medical Sciences Innovation Fund(CI2021A05501);TCM Clinical Basic Discipline Innovation Team Project of China Academy of Chinese Medical Sciences Innovation Fund(CI2021B003);Basic Research Funds for Free Exploration Project of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Z0856,Z0863,Z0855).

摘　　要：Objective:To analyze clinical trials of traditional medicine(including Chinese herbal medicine and nonpharmacological therapies)for the treatment of type 2 diabetes mellitus(T2DM)registered in the International Clinical Trials Registry Platform(ICTRP),and accordingly to explore their clinical trial registration characteristics,development trend and intervention status,in an attempt to provide references for future research design,diagnosis and management of traditional Chinese medicine therapy for T2DM.Methods:The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13,2023,to analyze the time of registration,country and institution of the study,source of funding,type and design of the study,randomization and blinding methods,clinical staging,therapeutic measures,and main therapeutic effect indexes.Descriptive statistical analysis was performed using R4.3.0 and Excel software.Results:A total of 774 clinical trials for T2DM treatment were included,of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies.The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms,with the most registrations in Iran,China,and Australia,and the top 3 registration platforms were the Iranian Clinical Trial Registry,the Australian New Zealand Clinical Trials Registry,and the ICTRP.Universities(551,71.19%)were the main funding sources.Intervention studies(750,96.90%)were the primary study type,including randomized controlled trials(432,56.4%),and 225 studies mentioned the blinding method.A total of 530(68.48%)with a sample size≤100 were included.Study phases were predominantly phase 2 and phase 3(108,51.43%).The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines(mainly ginseng and astragalus compound),nonpharmacological therapies(mainly exercise and diet thera

关 键 词：type 2 diabetes mellitus traditional medicine International Clinical Trials Registry Platform nonpharmacological therapies Chinese herbal medicine 

分 类 号：R58[医药卫生—内分泌]