Objective To evaluate the efficacy and safety of Xiaoer Jinqiao Granules（小儿金翘颗粒） for mild influenza in the treatment of children with influenza of wind-heat syndrome. Methods Randomized layered block

parallel control of positive drugs

non-inferiority test

and multi-center clinical trial design were used. A total of 240 children were included as the subjects and were randomly divided into treatment group and control group equally. The treatment group was given Xiaoer Jinqiao Granules and the control group was given Oseltamivir Phosphate Granules for 5 days and 2 days for follow-up. The clinical recovery time

complete antipyretic time

area under the curve of CARIFS symptom dimension and time

incidence of complications

incidence of severe and critical illness

efficacy of traditional Chinese medicine syndromes（curative rate） and safety indicators were compared between the 2 groups. Results A total of 240 children were enrolled. Among of them

the full analysis set（FAS） included 229 cases

perprotocol set（PPS） included 200 cases

and safety set（SS） included 233 cases. After treatment

the median time of clinical recovery in the treatment group and the control group were 3 days. There was no significant difference between the 2 groups（P>0.05）. The accelerated failure time model was used. According to the non-inferior standard of 0.75

the treatment group was not inferior to the control group. The conclusions of PPS and FAS analysis were consistent. For the secondary indicators

the antipyretic time of treatment group the and control group were 42 hours and 36 hours respectively. Compared between the 2 groups

there was significantly difference in FAS（P<0.05）

but there was no significantly difference in PPS（P>0.05）. There was no significant difference between the groups in the area under curve of CARIFS symptom dimension score

the incidence of complications

severe cases and critical illness

as well as TCM syndrome efficacy（curative rates）（P>0.05）. In the process of treatment

there were 23 cases of adverse events in the treatment group and 18 cases of adverse events in the control group. Among of them

there were 9 cases of adverse reactions in the treatment group and 10 cases of adverse reactions in the control group. There was no significant difference between the groups in the incidence of adverse incidents and adverse reactions（P>0.05）. Conclusion Xiaoer Jinqiao Granules in the treatment of patients with mild influenza can reduce the course

and its efficacy was not inferior to Oseltamivir Phosphate Granules

with good clinical safety.