Analysis on the current status of clinical trial registration of the TCM treatment for functional dyspepsia
10.3760/cma.j.cn115398-20250206-00033
- VernacularTitle:中医药治疗功能性消化不良临床试验注册现状分析
- Author:
Zhongyi ZHU
1
;
Guowei PU
;
Fengye JI
;
Sujing LI
;
Jing LI
;
Yan YANG
Author Information
1. 首都医科大学附属北京儿童医院中医科，北京 100045
- Keywords:
Traditional Chinese Medicine Therapy;
Functional Dyspepsia;
Clinical Trial Registration
- From:
International Journal of Traditional Chinese Medicine
2025;47(12):1752-1758
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the registration status of clinical trials of TCM treatment for functional dyspepsia (FD); To provide references for relevant clinical trial registration and implementation.Methods:The clinical registration trials of TCM for the treatment of FD were retrieved from ChiCTR and clinicaltrials.gov until January 1st, 2025. Excel 2019 was used to extract and analyze study characteristics, including basic information (registration time, country/region, institution, funding source), study features and quality (study type, trial design, phase, number of centers, sample size, interventions, outcome measures, methodological quality, reporting quality), as well as recruitment status and ethical review.Results:A total of 89 registered studies were included. Registration began in 2008 with 3 studies, peaking in 2021 with 14 studies. The studies involved 6 countries, with domestic trials covering 18 provincial-level regions in China and 52 clinical trial institutions. Primary funding sources were national funding and pharmaceutical company support. Most studies were interventional with randomized parallel-controlled designs, commonly using simple randomization. Post-marketing drug trials were the most frequent phase, and single-center trials predominated, involving a total sample size of 19 776 cases. Common interventions included acupuncture/massage and Chinese patent medicines. Frequently used outcome measures were effectiveness rate, symptom evaluation, and quality of life assessment, though issues existed with non-standardized reporting and lack of TCM-specific indicators. Methodological quality needed further improvement.Conclusions:Although the number of registered clinical trials of TCM treatment for FD has increased, the overall quantity remains insufficient. Researchers should emphasize optimization of registration details and study protocols to further enhance registration quality.
