Abstract: AIM: To evaluate the efficacy and safety of SanAo Tablet in treating acute bronchitis with the syndrome of wind-cold attacking the lung.METHODS: A multicenter, randomized, double blind, double dummy, controlled trial,non-inferiority was conducted. A total of 240 patients with acute bronchitis were randomly divided into two groups: a treatment group (120 patients) were treated with SanAo Tablet and TongXuanLiFei Oral Liquid Analogue, acontrol group (120 patients) were treated with TongXuanLiFei Oral Liquid and SanAo Tablet Analogue. The therapeutic course of both groups was 7 days.RESULTS: For the clinical effective and curative rate, the treatment group obtained better effects than control group(P<0.05).For the effective and curative rate of TCM Syndrome, the treatment group showed a better clinical effect(P<0.05).SanAo tablet had significantly relieved the symptoms of cough and spitting sputum,compared with TongXuanLiFei Oral Liquid, SanAo tablet showed a better clinical effect(P<0.05).Onset time of cough and spitting sputum: there is no significant difference between two groups.The change amount of TCM syndrome total integral before and after treatment is higher in SanAo Tablet group than in TongXuanLiFei Oral Liquid group(P<0.05).CONCLUSION: SanAo Tablet is effective and safe in treating wind-cold attacking the lung pattern of acute bronchitis.

Key words: SanAo Tablet, TongXuanLiFei Oral Liquid, Pattern of wind-cold attacking the lung, Acute bronchitis, Randomized controlled trial