Objective To evaluate the therapeutic effect, safty and tolerance of Gankeshuangqing Capsule in the treatment of patients suffering from wind-heat syndrome (acute upper respiratory infection or acute bronchitis). Methods The clinical trials were designed multicentered, double blind, double dummy, randomized and parallel positive drug controlled. A total of 289 patients participated in the trials. Those who suffered from acute upper respiratory infection were given throat virus-detection to make a definite diagnosis of the origins of disease. Results Among the 40 patients who were diagnosed with virus infection, 81.82% in Gankeshuangqing group were healed, but only 50.00% in control group, and significant differences were observed between the two groups (Plt;0.05). At the end of the third day of treatment, the rates of cure and excellence in patients suffering from acute upper respiratory infection were 80.00% in Gankeshuangqing group, and 68.57% in control group, and both groups showed good therapeutic effect，but there was no significant difference between the two groups (Pgt;0.05). At the end of the seventh day of treatment, the rates of cure and excellence in patients suffering from acute bronchitis were 82.35% in Gankeshuangqing group, and 63.77% in control group, and both groups showed good therapeutic effect, and there were significant differences between the two groups (Plt;0.05)；only one patient in Gankeshuangqing group had constipation during the treatment, but there was no evidence showing that it is caused by Gankeshuangqing. Conclusion The results show that Gankeshuangqing Capsule has a definite effect on wind-heat syndrome (acute upper respiratory infection or acute bronchitis) with good safety.