Objective To evaluate the safety and efficacy of Jinlianqingre capsule in treatment of acute upper respiratory tract infection （external wind-heat syndrome）. Methods A multi center, double-blind, double dummy, randomized controlled trial was conducted. A total of 226 patients with acute upper respiratory tract infection were randomized into two groups：the trial group （116 patients）received Jinlianqingre capsule and the control group （110 patients） received Jinlianqingre granule. The therapeutic courses of both groups were 3 days. Results The total significant effective rates and the total effective rates of acute upper respiratory tract infection were 66.38 % and 95.69% in the trial group respectively, and 60.91% and 95.45% in the control group respectively. There were no statistical differences between the two groups （P 〉0.05）. The total significant effective rates and the total effective rates of Chinese medicine symptoms were 70.69% and 97.41% in the trial group respectively, and 69.09% and 93.64% in the control group respectively. There were no statistical differences between the two groups （P 〉0.05）. Besides, the efficacy of Jinlianqingre capsule was better than that of Jinlianqingre granule with respect to fever duration after treatment; there were statistical differences between the two groups （P〈0. 05 ）. No adverse effects were found in the trial group. Conclusions Jinlianqingre capsule is effective and safe in treatment of acute upper respiratory tract infection （external wind-heat syndrome）.