Analysis on Clinical Trial Registration Characteristics of TCM Prevention and Treatment of Stroke
10.19879/j.cnki.1005-5304.202401315
- VernacularTitle:中医药防治脑卒中注册临床试验特征分析
- Author:
Tianyi ZHANG
1
;
Siming NI
;
Yuan GAO
;
Weidong SHEN
Author Information
1. 上海中医药大学附属曙光医院,上海 201203;上海中医药大学针灸推拿学院,上海 201203
- Publication Type:Journal Article
- Keywords:
stroke;
TCM;
clinical trial registration;
data mining
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2025;32(4):65-71
- CountryChina
- Language:Chinese
-
Abstract:
Objective To review the clinical trial registration characteristics of TCM prevention and treatment of stroke;To provide reference for future relevant clinical trials.Methods Clinical trials of TCM prevention and treatment of stroke registered on ChiCTR and NCT from the establishment of the databases to August 31,2023 were retrieved.Excel 2019 was used to remove duplication and extract relevant data.SPSS 27.0 was used to analyze the included data and drown corresponding charts.The characteristics of trails were summarized.Results Totally 540 registered clinical trials were included,among which,449(83.15%)were from ChiCTR and 91(16.85%)were from NCT.The number of registered was is generally increasing year by year.The included research involved 8 countries,of which 29 provinces of China were involved;213 institutions and 391 researchers were involved.The main source of funding was government finance(52.41%);a total of 216 368 participants were included in these trials,with the majority of trials having a sample size of 50-100 cases(32.22%).The main research type was intervention study(88.70%),and the study design was mostly randomized controlled trial(82.59%).Most of the trials(39.63%)did not clearly report the blind method,followed by double blind clinical trail(21.67%)and evaluator blind clinical trial(13.70%).Clinical trials focused on the full cycle of stroke management,including acute,convalescent,sequelae,and stroke prevention.Among them,the study of sequelae stage of stroke accounted for the largest proportion(62.04%),which specifically covered motor dysfunction,cognitive mental dysfunction,swallowing disorders,etc.The main intervention measures were acupuncture(42.41%),followed by Chinese patent medicine(21.12%)and tuina(10.37%).The main outcome evaluation indexes were motor function evaluation(17.10%)and nerve function evaluation(14.56%).Conclusion The clinical research on the TCM prevention and treatment of stroke is in a period of rapid growth with increasing attention and deepening of the research,which is conducive to improving the prognosis of patients.However,there are still some problems,such as studies with weak systematicness,unreasonable proportion structure of intervention measures,and strong subjectivity of outcome evaluation indicators.
