Analysis on Registration Status of TCM Clinical Trials of Sepsis Based on WHO ICTRP and ChiCTR
10.19879/j.cnki.1005-5304.202408243
- VernacularTitle:基于WHO ICTRP及ChiCTR的中医药干预脓毒症临床试验注册现况分析
- Author:
Wenjing YIN
1
;
Kai XIE
;
Xinyu MIAO
;
Xiaoxuan HE
;
Haifeng WANG
Author Information
1. 河南中医药大学第一附属医院,河南 郑州 450000;河南中医药大学第一临床医学院,河南 郑州 450000
- Publication Type:Journal Article
- Keywords:
sepsis;
TCM;
clinical trial registration
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2025;32(9):48-53
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the current status and characteristics of registered clinical trials on TCM interventions for sepsis;To provide references for relevant clinical trial registrations.Methods Clinical trials on TCM interventions for sepsis registered in the World Health Organization International Clinical Trials Registry Platform(WHO ICTRP)and the Chinese Clinical Trial Registry(ChiCTR)from inception to June 2024 were retrieved.Data on registration time,registry centers,regions,institutions,participating centers,funding sources,trial design,phase,sample size,randomization methods,blinding,interventions,disease types,and outcome measures were analyzed using Excel 16.0.Results A total of 118 TCM intervention trials for sepsis were included,registered regions involving Guangdong,Jiangsu,and Shanghai,with institutions including Guangdong Provincial Hospital of Chinese Medicine,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,and Jiangsu Provincial Hospital of Traditional Chinese Medicine.Most trials were single-center studies(94,79.66%),funded primarily by hospitals(38)and local governments(36).The majority were interventional studies(105,88.98%),with phases concentrated in pilot/exploratory studies and Phase Ⅳ trials(52).Sample sizes were mostly 60-99 cases(51).Randomized controlled trials predominantly used simple randomization(65)and double-blinding(22).Interventions mainly included empirical formulas,Chinese patent medicines,and classical prescriptions,targeting conditions such as gastrointestinal dysfunction and lung injury,with primary outcomes including SOFA,APACHE Ⅱ,and mortality rate.Conclusion The number of TCM registered clinical trials for sepsis has generally increased.There are some problems,such as uneven distribution of test areas,poor standardization and integrity of registration information,and the advantages and characteristics of TCM need to be further highlighted.
