Multi-center phase Ⅲ clinical trial of Qinxiang Qingjie Oral Liquid for treating pediatric patients of acute upper respiratory infection with syndrome of heat in both exterior and interior
HU Si-yuan
MA Rong
CHEN Xin-yu
WEI Xiao-wei
CHENG Yan
QI Zheng
HUANG Wen-yu
LI Yan-ning
Abstract：Objective:To confirm the efficacy and safety of Qinxiang Qingjie Oral Liquid in treating pediatric patients of acute upper respiratory infection with the syndrome of heat in both exterior and interior.Methods:A multi-center,stratified blocked randomization,positive drug (Huangzhihua Oral Liquid) parallel control,doubleblind,non-inferiority design was adopted to this study.Results:A total of 480 cases were enrolled,with 360 in the treatment group and 180 in the control group.The total cure-remarkable-effectiveness rates of disease in the treatment and control groups were 77.8％ and 76.8％,respectively (per protocol analysis,PPS),and the total cure-remarkable-effectiveness rates of syndrome in the treatment and control groups were 78.6％ and 77.5％ (PPS),respectively.The results of non-inferiority analysis showed that the efficacy for either disease or syndrome in the treatment group was non-inferior to that of the control group.During the study,the treatment group reported 3 cases of mild diarrhea,1 case of moderate diarrhea,and the control group reported 2 cases of mild vomiting,1 case of mild diarrhea.The incidences of adverse reactions in the treatment and control groups were 1.1％ and 2.5％,respectively,and the difference between the two groups was not significant.Conclusion:The curative effect of Qinxiang Qingjie Oral Liquid is not inferior to Huangzhihua Oral Liquid in treating acute upper respiratory infection in pediatrics.In addition,Qinxiang Qingjie Oral Liquid has good safety.
Keywords：Qinxiang Qingjie Oral Liquidacute upper respiratory infectionpediatricssyndrome of heat in both exterior and interiormulti-centerclinical trial
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1152-1156 )