Objective To observe therapeutic effect of Xiao’er Chiqiao Qingre Granules（ 小儿豉翘清热颗粒） in treating children with cold of wind-heat with stagnation syndrome. Methods Divided 386 cases of children with cold of wind-heat with stagnation syndrome into treatment group（ 260 cases） and control group（ 126 cases） according to multicenter

central randomization

parallel control design. The treatment group was given Xiao’ er Chiqiao Qingre Granules while the control group was given Jian’ er Qingjie Liquid（ 健儿清解液）

both treated for 3 days.Compared scores of main symptoms（ including fever

distending pain of stomach and abdomen）

secondary symptoms（ including pharyngeal red and swollen

aversion to wind and cold

sweating

cough and face color） and scores of total syndromes of children in two groups before and after treatment. And also evaluated the clinical curative effect.Results The curative rate in the treatment group was 22. 69% with total effective rate 68. 08%; the curative rate in the control group was 14. 29%

with the total effective rate 51. 59%. There was statistical significance in difference of curative rate and the total effective rate between groups（ P < 0. 05）. Scores of main symptoms

secondary symptoms and total symptoms all remarkably decreased than that before treatment（ P < 0. 05）. Scores of main symptoms and total symptoms remarkably decreased compared with that in the control group（ P < 0. 05）; there was no statistical significance in difference of scores of secondary symptoms in two groups after treatment（ P > 0. 05）. Conclusion Xiao’er Chiqiao Qingre Granules could effectively improve clinical symptoms of children of cold with wind-heat with stagnation syndrome. It was especially effective in improving fever and distending pain of stomach and abdomen.