Analysis on the registration status of clinical trials of inflammatory bowel disease in Chinese Clinical Trial Registry and TCM registration trials
10.3760/cma.j.cn115398-20241228-00315
- VernacularTitle:中国临床试验注册中心炎症性肠病临床试验注册现状及中医药注册试验分析
- Author:
Shuxian MAO
1
;
Mingxin DONG
;
Xiangxue MA
;
Haomeng WU
;
Huan ZHENG
;
Yongzhuo HUANG
;
Shaogang HUANG
Author Information
1. 广州中医药大学第一临床医学院2023级硕士研究生，广州 510120
- Keywords:
Inflammatory bowel disease;
Clinical trial;
Chinese clinical trial registry;
TCM
- From:
International Journal of Traditional Chinese Medicine
2025;47(11):1602-1609
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically analyze the registration status of clinical trials related to inflammatory bowel disease (IBD) in China Clinical Trial Registry (ChiCTR); To focus on the characteristics and shortcomings of TCM research; To provide data support and theoretical basis for optimizing clinical trial design and improving the quality of TCM research.Methods:The IBD-related clinical trials registered by ChiCTR from the establishment of the database to September 18, 2024 were retrieved. SPSS 26.0 software was used to analyze the frequency of research objects, registration time, registration area and institution, source of funds, research type and design scheme, random method and blind method, trial staging and research center, sample size, intervention measures and outcome indicators.Results:There were 317 clinical trials of IBD. Shanghai, Jiangsu, Beijing, Guangdong and Zhejiang accounted for 72.87% of the total number of registrations. Most of the registered projects were intervention studies (51.42%), 48 studies used blind method, and randomized controlled study was the main research design type. In the 68 clinical trials related to TCM, the intervention measures were divided into 4 categories, of which Chinese materia medica was the most (42 items); the sample size was the most in the intervention study, with a total of 6 787 cases; the total frequency of outcome indicators was 1 866 times, and the quality of life and mental health were the most (147 items).Conclusions:The number of registered IBD clinical trials is generally increasing, but there may be problems such as uneven distribution of regions and institutions, poor design of sample size, blind method and other research, and non-standard filling of registration information. In the research of TCM treatment of IBD, it is suggested to further strengthen the depth and breadth, especially the characteristic therapy of TCM.
