Analysis of Traditional Chinese Medicine for Prevention and Treatment of Heart Failure Clinical Trial Registration Actualities and Quality
GUO Lijun
GAO Feng
WANG Yifei
ZHANG Hongwei
FU Shuangqing
SONG Lifang
ZHANG Xiujuan
MA Xiaochang
Abstract：Objective:To analyze the actualities and quality of the registered traditional Chinese medicine(TCM) for the treatment of heart failure ( HF)-related clinical trials,and to explore the characteristics and shortcomings of relevant studies on prevention and treatment of HF with TCM,so as to provide reference for the subsequent clinical trial design.Methods:Chinese Clinical Trial Registry and ClinicalTrials.gov were searched to collect the TCM for prevention and treatment of HF-related clinical trials from inception to December 31st,2023. Data of trials were collected. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).Results:A total of 128 registered clinical trials were included,involving 60 research institutions in 17 provincial administrative regions.The top 4 registries of trials were Beijing,Shanghai,Guangdong,and Tianjin.The top 3 funds in trials were originated from local,hospitals,and national funds. The main research type was intervention research ( 89. 26％). A total of 111 trials were designed as randomized parallel control studies,and 50.78％ trails were blinding.Most of the trials were single-center studies(64.06％),and the sample size of trials were concentrated between 61 to 199.Among the registered trials,self-prepared prescription related studies and Chinese patent drug accounted for the highest proportion.In addition,the total quality of registration completion of the two registries was 77.42％. Conclusions:At present,the overall trend of clinical trials for prevention and treatment of HF with TCM is positive. However,these trials contain unbalanced attributes such as distribution of registration area and organization,allocation of funds,poor standardization of trial design etc.The design of clinical trials and registration details are needed to be improved.
Keywords：heart failuretraditional Chinese medicineclinical researchregistration centerreporting quality
Publication Date：2024-12-16
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 4454-4460 )