Clinical trial design and evaluation of traditional Chinese medicine in the treatment of adenoid hypertrophy in children
LIU Ping
HU Si-yuan
CAI Qiu-han
LI Rui-ben
ZHOU Zi-nan
Abstract：Adenoid hypertrophy(AH)is a common pediatric disease and a clinically dominant disease in traditional Chinese medicine(TCM).According to the domestic and international clinical diagnosis and treatment guidelines,as well as randomized controlled trials of children with AH,incorperating the practical experience from the clinical trial center of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,this paper systematically outlines the key technical aspects of clinical trial design and evaluation for TCM in treating children with AH,from the aspects of clinical positioning,overall trial design,diagnostic criteria and TCM syndrome differentiation criteria,subject selection and withdrawal,treatment plan,trial procedure,effectiveness evaluation,safety observation,and quality control.This article aims to enrich the methodological content of clinical trial design and evaluation of TCM in pediatric diseases,improve the quality of clinical trial design and implementation,and promote the research and development of new TCM in pediatrics.
Keywords：traditional Chinese medicinechildrenadenoid hypertrophyclinical trialstrial designclinical evaluation
Publication Date：2025-02-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 292-296 )