Objective To evaluate the curative effect and safety of Kanggan Keli in treating infantile influenza.Methods A multicenter randomized

double-blind

double simulation

parallel control clinical trial was designed.Two hundred and forty children with influenza were divided into a treatment group（ 120 cases） and a control group（ 120 cases）. The treatment group was given oral Kanggan Keli and ribavirin particle analogue; while the control group was given oral Kanggan Keli analogue and ribavirin particle. The course in both groups was 7 days. During the course

medication was stopped at any time once the patient was recover

which was processed as the completed case.It was examined in both groups that time for body temperature return normal

time for clinical recovery

area under curve（ AUC） of main symptoms（ fever

headache

nasal obstruction

nasal discharge and sore throat）

and Chinese medicine syndrome effect and safety. Meanwhile

full analysis set（ FAS） and per protocol set（ PPS） analysis was adopted. Results The median time for body temperature return to normal by FAS was 32. 00 h in the treatment group

and 72. 00 h in the control group（ P < 0. 01）. The median time for clinical recovery by FAS was 56. 00 h in the treatment group

and 80. 00 h in the control group. The result of PPS was similar to that of FAS. There was significant difference between the two groups（ P < 0. 01）. AUC of fever and sore throat in the treatment group was smaller than that in the control group（ P < 0. 01）. The result of PPS and FAS was similar. For Chinese medicine syndrome effect

the total effective rate and the cured and markedly effective rate by FAS was 100% and 92. 50%

respectively in the treatment group

and 91. 67% and 72. 50% respectively in the control group; the total effective rate and the cured and markedly effective rate by PPS was 100% and 93. 40%

respectively in the treatment group

and 91. 26% and73. 79% respectively in the control group. The total effective rate and the cured and markedly effective rate in the treatment group were both higher than those in the control group（ P < 0. 01）. The result of PPS and FAS was similar.No side effect was found in both groups. Conclusion The effect of Kanggan Keli in treating infantile influenza seems better than ribavirin particle

with good safety.