Objective To observe the efficacy and safety of Children Shuangqing Granules on acute upper respiratory infection with exterior-interior heat syndrome.Methods Totally 420 cases of acute upper respiratory infection with exterior-interior heat syndrome were randomized into test group of 315 cases and control group of 105 cases. The test group was given Children Shuangqing Granules and the control group was given Children Resuqing Granules. The dosage for children younger than one-year old was one gram

for children of one year to three year old 2g

for children of four year to six year old 3g and for those of over seven years 4g

three times daily. The therapeutic effect

syndrome effect

time required for the restoration of normal temperature and side effect was observed after 3 days of treatment.Results The total effective rate of the test group and the control group was 83.23% and 60.95% respectively. The total effective rate of syndrome of the test group and the control group was 94.41% and 74.29% respectively

with significant difference between groups （P<0.05）. The single symptom effective rate in the test group was superior to that in the control group （P<0.05）. The time required to restore the normal temperature was （24.5±18.2）h and （32.5±19.6）h in the test group and control group respectively

with significant difference between groups （P<0.05）. No adverse reaction was found in both groups.Conclusion Children Shuangqing Granules is effective and safe for acute upper respiratory infection with exterior-interior heat syndrome.