Objective To evaluate the effectiveness and safety of Xiaoer Resuqing Syrup（小儿热速清糖浆） in the treatment of children acute upper respiratory tract infection with heat syndrome of both exterior and interior. Method Block randomization

double blind double simulation

positive drug control

multi-center clinical research methods were used. It is planned to enroll 480 cases

including 360 cases in the treatment group and 120 cases in the control group. The treatment group was treated with Xiaoer Resuqing Syrup and Xiaoer Qingrening Granule（小儿清热宁颗粒） simulator

while the control group was treated with Xiaoer Qingrening Granules and Xiaoer Resuqing Syrup simulator. The course of treatment was 5 days. The time to complete antipyretics

the efficacy of constipation

the efficacy of traditional Chinese medicine（TCM） syndromes

the disappearance rate of single symptoms

the instantaneous antipyretic time and the duration of antipyretics

safety indicators were compared between the 2 groups. Results A total of 468 cases were included

including 352 cases in the treatment group and 116 cases in the control group. The results of the full analysis data set（FAS） showed that the median time to complete fever in the two groups were both 48 hours. The risk ratio（HR） and 95% confidence interval between the groups were estimated by the COX regression model. After adjusting the influence of central factors

according to the non-inferiority standard of 0.67

the treatment group was non-inferior to the control group. After treatment

the total effective rate of constipation in the treatment group and the control group was 96.54% and 88.70%

respectively. The differences between groups were statistically significant（P<0.05）; the curative rate of TCM syndromes in the treatment group and the control group were respectively 46.40%

and 31.30%（P<0.05）. A total of 7 cases of adverse events were found in this study including 4 cases（1.15%） in the treatment group and 3 cases（2.59%） in the control group. Conclusion Xiao′er Resuqing Syrup has the effect of shortening the heat course in the treatment of children acute upper respiratory tract infection with heat syndrome of both exterior and interior. The curative effect is not inferior to that of Xiaoer Qingrening Granules

and both drugs were of good safety.