Objective To evaluate the clinical effect and safety of Gankeshuangqing capsule in the treatment of acute upper respiratory infection (AURI).Methods A total of 144 patients with wind-heat syndrome (acute upper respiratory infection) were recruited and randomized into the Gankeshuangqing group (administered with Gankeshuangqing capsule and symptomatic treatment for 3 days) and the ribavirin group (administered with ribavirin tablets and symptomatic treatment for 3 days). And the severity scores of pathogenetic conditions, efficacy rates and adverse drug reaction were estimated at the end of the experiment. Results A total of 144 patients (72 in the Gankeshuangqing group, 72 in the ribavirin group) were enrolled in this trial, of whom 9 were dropped out (3 from the Gankeshuangqing group, 6 from the ribavirin group) and 11 were excluded (4 from the Gankeshuangqing group, 7 from the ribavirin group). A significant difference was observed in the rates of cure and excellence: 85.51% (59/69) for the Gankeshuangqing group, and 66.67% (44/66) for the ribavirin group, respectively (Plt;0.05) (FAS data set). A significant difference was observed in the rates of cure in fervescence, pharyngodynia and pars nasalis catarrhus symptome: 70.00%, 78.26%, 56.90% in the Gankeshuangqing group, and 40.38%, 51.52%, 36.21% in the ribavirin group, respectively (Plt;0.05) (FAS data set). There was no significant difference in the rates of cure in tussis between the two groups: 32.08% for the Gankeshuangqing group, and 34.00% for the ribavirin group, respectively (Pgt;0.05) (FAS data set). There were 2 adverse drug reactions observed in the ribavirin group, whose white blood cell count was decreased, but in the Gankeshuangqing group, no adverse drug reaction was found. Conclusion The results indicate that Gankeshuangqing Capsule shows a definite effect on wind-heat syndrome (acute upper respiratory infection) with good safety.