Objective To evaluate the effectiveness and safety of Fengliaochangweikang Granule（枫蓼肠胃康颗粒） in the treatment of infantile acute diarrhea with damp-heat pattern. Methods A randomized

double-blind

multicenter clinical trial was conducted

and the non-inferiority design was used. A total of 240 children at the age of six months to five years old were recruited from 12 hospitals in China

and they were randomly divided to either receive Fengliaochangweikang Granule（treatment group） or Er Xie Ting Granule（儿泻停颗粒

control group）

with 120 patients in each group. Both groups were treated threee times a day for five days. The 5-day diarrhea disappearance rate

3-day diarrhea disappearance rate

3-day normalization rate of defecation frequency and stool characteristics

duration of diarrhea

the effectiveness rate based on traditional Chinese medicine（TCM） syndrome scores

and safety outcomes were assessed. Results The 5-day diarrhea disappearance rate of the treatment group was 87.29% while that of the control group was 84.62%（P>0.05）; the lower limit of 95% confidence interval（CI）（-0.0621

0.1155）was greater than the non-inferior margin-0.15

accepting that assumption that the treatment group was not inferior to the control. There were no significant differences between the treatment group（60.50%） and the control（48.72%） in the 3-day diarrhea disappearance rate（P>0.05）

and in the normalization rate of defecation frequency and stool characteristics（P>0.05）. The median duration of diarrhea stop in the treatment group and the control group was 92 hours and 96 hours respectively. The effectiveness rate based on TCM syndrome scores was not statistically different between groups. There were no adverse events in the treatment group

while one each case of elevated alanine aminotransferase and elevated aspartate aminotransferase appeared in the control group（P>0.05）. Conclusion Fengliaochangweikang Granule is not inferior to Er Xie Ting Granule in improving the diarrhea disappearance rate for children at the age of six months to five years with acute diarrhea of damp-heat pattern

and is found to be safe.