Objective To objectively evaluate the therapeutic effect of Shanggan Granules [granules for upper respiratory tract infection （URTI）] for acute URTI with fever.Methods A total of 270 patients from 6 clinical research centers were randomized into the trial group

control group and placebo group

with 90 in each.The trial group was given Shanggan Granules and analog Bufferin Cold Tablets orally.The control group was given Bufferin Cold Tablets and analog Shanggan Granules orally.The placebo group was given analog Shanggan Granules and analog Bufferin Cold Tablets orally.The treatment lasted for 3 days.The immediate defervescence time

immediately antipyretic efficacy

onset time

antipyretic time and clinical cure rate was observed.Results The body temperature was significantly decreased in the trial group and control group in the 1st

2nd

3rd and 4th hour after administration （P<0.01）.The body temperature was significantly decreased in the placebo group in the 2nd

3rd and 4th hour after administration （P<0.01）.Comparing with the placebo group

the body temperature decrement in the trial group and control group was significantly different at each time point and the previous time point in the 1st

2nd

3rd and 4th hour after administration （P<0.05 or P<0.01）.The immediately antipyretic efficacy in the trial group

control group and placebo group was 67.06%

67.82% and 40.23% respectively.The immediately antipyretic efficacy in the trial group and control group was superior to that in the placebo group （P<0.01）.The onset time and antipyretic time in the trial group and control group was shorter than that in the placebo group （P<0.05）.The clinical cure rate in the placebo group

control group and trial group was 51.72%

70.11% and 84.71% respectively.The clinical cure rate in the trial group was significantly higher than that in the control group and placebo group （P<0.05 or P<0.01）.The clinical cure rate in the control group was significantly higher than that in the placebo group （P<0.05）.Conclusion Shanggan Granules is effective for acute URTI with fever in lowering the body temperature

reducing the duration of fever and relieving clinical symptoms.