OBJECTIVE: To assess the efficacy and safety of Reduqing granules in patients with common cold with wind-heat syndrome (CCWHS).METHODS: A randomized, double-blind, double-dummy, parallel, positive-controlled trial included 72 CCWHS patients was performed.The participants were randomly assigned to two groups, Reduqing (RDQ) group and Lianhuaqingwen (LHQW) group, in a1:1ratio.Patients in RDQ group received Reduqing granules and dummy Lianhuaqingwen capsules three times a day and patients in LHQW group received Lianhuaqingwen capsules and dummy Reduqing granules three times daily.The duration of treatment and follow-up were four days.RESULTS: There were no statistically significant differences in total markedly effective rate and total effective rate between RDQ group and LHQW group after treatment.Traditional Chinese Medicine (TCM) symptom score was significantly reduced after treatment in RDQ group, as well as in LHQW group.However, the difference of change in TCM symptom score between two groups was not statistically significant (P > 0.05).There were no significant differences between two groups in the median time to fever relief [RDQ group (4±8) h vs LHQW group (4±5) h] or the median time to fever clearance (RDQ group 47 h vs LHQW 36 h).No serious adverse events were reported during the study.CONCLUSION: Compared with Lianhuaqingwen capsules, Reduqing granules achieved similar therapeutic effect in the treatment of CCWHS and no drug-related adverse events were reported during the study.Therefore, Reduqing granules might be effective and safe in the treatment of CCWHS.