Analysis on status of clinical trial registration of TCM treatment of cervical spondylosis
10.3760/cma.j.cn115398-20240806-00045
- VernacularTitle:中医药治疗颈椎病的临床试验注册现状分析
- Author:
Ziming CAI
1
;
Jintao WU
;
Qinghe YU
;
Jinzhu LIANG
;
Ye RUAN
;
Shuhui LIN
;
Wenping LIN
Author Information
1. 广州中医药大学附属深圳平乐骨伤科医院2023级硕士研究生，深圳 518118
- Keywords:
Cervical spondylosis;
Traditional Chinese Medicine;
Clinical trials;
Registration;
Chinese Clinical Trial Registry;
ClinicalTrials.Gov;
Randomized controlle
- From:
International Journal of Traditional Chinese Medicine
2025;47(5):692-698
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To collect registered clinical research plans on TCM characteristic therapies for treating cervical spondylosis; To explore their research registration status; To provide references for future clinical trial registration and implementation.Methods:Clinical research on TCM characteristic therapies for treating cervical spondylosis was retrieved from ChiCTR, ITMCTR and Clinical Trials. gov from the establishment of the databases to July 1, 2024. Excel 2019 was used to conduct descriptive statistics on registration time, registration area and institution, funding source, research type and design scheme, research participation center and sample size, cervical spondylosis type, intervention measures, outcome indicators, reporting quality, research openness and methodological application.Results:A total of 138 clinical trials for the TCM treatment of cervical spondylosis were included, of which 136 were registered by domestic researchers in 22 provincial-level administrative regions. The top three in terms of registration numbers were Shanghai, Guangdong Province, and Beijing. Additionally, 2 were registered by foreign researchers in Egypt and Malaysia. The main sources of funding were 50 local finances, followed by 26 hospital subsidies and 18 national finances. The intervention research accounted for the largest proportion of research types, with 123 items (89.13%). The research center mainly focused on single center studies (98 projects). Most randomized controlled trials (115 trials) described randomization methods, while a small number of randomized controlled trials (50 trials) indicated blinding. The intervention measures were mostly combined with TCM therapy, and the outcome indicators were mainly efficacy indicators, with fewer safety indicators.Conclusions:At present, clinical trial registrations for TCM treatment of cervical spondylosis are increasing, but issues remain, such as poor study design, uneven distribution, and incomplete information. It is recommended to refine registration details, optimize study protocols, and promote high-quality clinical research.
