Objective To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection. Methods The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days. Results Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (Plt;0.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (Plt;0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation.Conclusion Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.