Analysis on the current status of clinical trial registration for TCM treatment of heart failure in China
10.3760/cma.j.cn115398-20240924-00268
- VernacularTitle:中国中医药治疗心力衰竭临床试验注册现状分析
- Author:
Chen LIU
1
;
Yao PENG
;
Donghui LIANG
Author Information
1. 南方医科大学中医药学院2022级硕士研究生，广州 510515
- Keywords:
Heart failure;
Clinical trial registration;
TCM
- From:
International Journal of Traditional Chinese Medicine
2025;47(6):855-859
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the current status of clinical trial registration for TCM treatment of heart failure.Methods:The clinical trials of TCM in the treatment of heart failure registered by China Clinical Trial Registry (ChiCTR) from the establishment of the database to June 30, 2024 were retrieved. Excel 2019 was used to input data and register time, registration area and institution, registration center and sample size, funding source, intervention measures, outcome indicators, random methods and blind methods were used for frequency analysis.Results:A total of 71 clinical trials of TCM in the treatment of heart failure in China were included, involving 13 provincial-level administrative regions. There were 39 clinical trial institutions participating in the registration, with Shanghai (16 items), Beijing (15 items), and Tianjin (12 items) ranking at the top in terms of registration numbers; the funding mainly relied on local finances, followed by national finances and hospital grants; in the registered projects, interventional studies accounted for the majority, mainly grouped through random number table methods, and only a small number of trials used blinding methods, with single-center participation being the norm; in terms of intervention measures, mainly Chinese patent medicines were used, while TCM decoctions were used less frequently. Outcome indicators were mainly efficacy indicators such as biochemical results and echocardiography, lacking monitoring of safety indicators.Conclusions:The number of clinical trial registrations for TCM in the treatment of heart failure in China is relatively small, but it shows a trend of increasing year by year. In terms of intervention measures, the treatment methods are also continuously enriching. However, there are still issues with clinical trials of TCM for the prevention and treatment of heart failure, such as insufficient awareness of registration among researchers, unbalanced regional and institutional distribution, and the need for improvement in the use of randomization and blinding methods.
