Analysis on Clinical Trial Registration Status of TCM for the Treatment of Diabetic Nephropathy
10.19879/j.cnki.1005-5304.202409561
- VernacularTitle:中医药治疗糖尿病肾病临床试验注册现状分析
- Author:
Jiawei ZHANG
1
;
Zhifen ZHAO
1
;
Xiangge REN
1
;
Peidong ZHAO
1
;
Shoudao LI
1
;
Tengfei SONG
1
;
Wensheng ZHAI
1
Author Information
1. 河南中医药大学第一附属医院儿科医院,河南 郑州 450000;河南中医药大学儿科医学院,河南 郑州 450000
- Publication Type:Journal Article
- Keywords:
diabetic nephropathy;
traditional Chinese medicine;
clinical trials;
China Clinical Trial Registry;
Clinical Trials.gov
- From:
Chinese Journal of Information on Traditional Chinese Medicine
2025;32(10):73-79
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the current status of clinical trial registration in the TCM treatment of diabetic nephropathy(DN);To provide references for the registration and implementation of relevant clinical trials.Methods Clinical trials about TCM treatment for DN registered in the Chinese Clinical Trial Registry(ChiCTR)and the U.S.Clinical Trial Registry(ClinicalTrials.gov)from their inception to August 18,2024 were retrieved.The following information was analyzed:registration year,geographical distribution,funding sources,TCM syndrome patterns of participants,number of research centers,sample size,study type,study design,randomization method,blinding method,intervention measures,outcome indicators and safety indicators.Results A total of 88 clinical trials were included,comprising 79 interventional studies and 9 observational studies.The number of registrations has increased annually.The domestic registered trials were distributed across 17 provincial-level administrative regions in China,with Beijing and Shanghai having the highest number of registrations.The primary sources of funding were local and national government funds.The most common TCM syndrome pattern among participants was qi-yin deficiency with blood stasis.Most trials were single-center studies,with the majority having a sample size between 31 and 60.The predominant study type was interventional,mostly randomized controlled trials(RCTs),with simple randomization being the most frequently used method.31 trials reported blinding methods,with double-blinding being the most common.The intervention measures were mostly oral Chinese patent medicines or TCM compounds,and the outcome indicators were mainly efficacy indicators,with less safety indicators.Conclusion The number of registered clinical trials on TCM treatment for DN has increased annually;however,the overall number remains limited.There is uneven regional distribution and incomplete registration information for various factors such as randomization methods,blinding methods,number of research centers,intervention measures,and outcome indicators.
