To evaluate the efficacy and safety of Ertong Qingyan Jiere Oral Liquid in treatment of infantile acute pharyngitis with Lung-stomach excess-heat syndrome. Methods:This study was a multi-center clinical research with the methods of randomized, double-blind, parallel controlled. A total of 240 cases of children with bacterial infection were enrolled and divided into experimental group, positive control group and placebo group in the rate of 2:1:1. All patients took Azithromycin Granules as basic treatment, while the experimental group took Ertong Qingyan Jiere Oral Liquid，positive control group took Pudilan Xiaoyan oral liquid，placebo group took the simulant of them. Treatment course lasted for 5 days. The curative effects of throat pain, efficacy of disease and Traditional Chinese Medicine (TCM) Syndrome were observed. Results:Effectiveness evaluation. The markedly effective rate of sore throat in the experimental, positive control and placebo groups were 90.27%、81.82%、60.71% respectively. There were significant differences between the 3 groups (P<0.05). Experimental group was better than the placebo group, and non-inferior to positive control group. There were significant differences between the 3 groups in the markedly effective rate of disease efficacy and TCM syndrome efficacy (P<0.05). Experimental group was better than the placebo group, and non-inferior to control group. There were significant differences between the 3 groups in the disappearance rate of symptoms of cough, ozostomia, yellow urine, dry stool. For the disappearance rate of cough, yellow urine, dry stool, experimental group was better than other two groups. Safety evaluation. There were not reports about adverse events in 3 groups, and no significant differences in the incidence of adverse events between groups (P>0.05). Conclusion:Ertong Qingyan Jiere Oral Liquid combined with azithromycin granule was non-inferior to Pudilan Xiaoyan oral liquid combined with azithromycin granules in lightening the throat pain of children with acute pharyngitis (lung-stomach excess-heat syndrome), and was superior to azithromycin granules alone with good safety.