Objective To evaluate the efficacy and safety of Xiao′er Qingfei Granules（小儿清肺颗粒） in treating children acute bronchitis with syndrome of phlegm-heat obstructing lung. Methods The stratified blocked randomization

positive drug parallel contrast

double blind

double dummy

non inferiority test

and multi-centered research were applied to this study. A total of 240 cases were divided into a treatment group and a control group

with 120 cases in each group. The treatment group was given oral Xiao′er Qingfei Granules and Jizhi Syrup（急支糖浆） simulator

and the control group was given Jizhi Syrup and Xiao′er Qingfei Granules Simulator. The course of treatment for both groups was 5 days. After treatment

the disappearance time of the main symptoms（cough

expectoration）

the onset time of antitussive

the efficacy of the disease

the efficacy of traditional Chinese medicine（TCM） syndromes

the time for complete fever reduction and safety were evaluated. Results There was no statistically significant difference between groups in main symptoms（cough

expectoration） disappeared time

cough onset time and complete antipyretic time（P

>

0.05）. After non-inferiority test

the therapeutic effects of the treatment group was not inferior to that of the control group

and the two groups had similar effects. After 5 days of treatment

the effective rates of TCM syndromes in the treatment group and the control group reached 98.33% and 92.37% respectively. The difference between groups in the full analysis data set（FAS） was statistically significant(P

FAS

=0.0285)

suggesting the treatment group was better than the control group in improving symptoms. There was no significant difference in adverse reactions between groups（P

>

0.05）. Conclusion Xiao′er Qingfei Granules has satisfactory effects on children acute bronchitis with syndrome of phlegm-heat obstructing lung

which is in line with those of Jizhi Syrup. In terms of TCM syndrome improving

Xiao′er Qingfei Granules is better

with good safety.