Objective: To evaluate the efficacy and safety of Mahuang Zhisou Capsule (MHZSC), a compound traditional Chinese herbal medicine, in treatment of acute upper respiratory tract infection of wind-cold syndrome.
Methods: A multi-center, double-blind, double dummy, randomized controlled trial was conducted. A total of 240 patients were randomized into treatment group (120 cases, treated with MHZSC) and control group (120 cases, treated with Mahuang Zhisou Pill). The therapeutic course was 3 days.
Results: Seven cases were excluded and three cases lost to follow-up. Two hundred and thirty-three cases entered intention-to-treat (ITT) analysis and 230 cases fitted in per-protocol population set (PPS) analysis. After treatment, the therapeutic effect of upper respiratory tract infection was calculated by ITT and PPS analysis respectively. The significant response rate and total response rate in the treatment group were 78.07% and 98.25％ (ITT and PPS), while the significant response rates in the control group were 70.59% (ITT) and 70.69％ (PPS), and the total response rates were 95.80％ (ITT) and 95.69％ (PPS) respectively. There were no significant differences in clinical efficacy between the two groups (P>0.05).
Conclusion: MHZSC is effective and safe in treatment of acute upper respiratory tract infection of external wind-cold syndrome.

Key words: herbal preparations, randomized controlled trials, double blind method, upper respiratory infections, wind-cold, common cold