Objective To evaluate the efficacy and safety of Shenling Jianpiwei Granules（SJG

参苓健脾胃颗粒） in treating children′s diarrhea with spleen deficiency pattern. Methods A multi-center

randomized

double-blind

double-dummy

positive drug parallel controlled trial was designed

where 238 patients were divided into treatment group and control group with 119 cases in each group. The treatment group took SJG（10 g per packet; 1/3 packet for 3 times daily if the age was ≥1 and <3 years old; 1/2 packet for 3 times daily if the age was ≥3 and <5 years old; 1 packet for twice daily if the age was ≥5 and <7 years old） plus Erbao Granules（儿宝颗粒） placebo（5 g per packet; 1 packet for twice daily if the age was ≥1 and <4 years old; 1.5 packet for twice daily if the age was ≥4 and <7 years old）; the control group took SJG placebo and Erbao Granules

and the usage and dosage were the same as those of treatment group. Both groups were treated for 10 days. Patients should stop taking the drug when they were clinically cured during the treatment

and were considered as completed cases. The rate of bowel movement returning to normal

diarrhea duration

total effectiveness rate

traditional Chinese medicine（TCM） symptoms improvement

and safety were assessed and compared between the two groups. Results The full analysis set（FAS） and per-protocol set（PPS） analyses showed that the rate of bowel movement returning to normal in the treatment group was 81.20% and 86.11%

respectively

while that of control group was 82.76% and 83.96%

respectively; the comparison between groups were not significantly different as 95% confidence interval was-0.1143 to 0.0831. The median diarrhea duration was 6 days in both groups. The FAS and PPS results of total effectiveness rate were 99.09% and 99.07% in the treatment group and 98.23% and 98.11% in the control group

with no significantly statistical differences between groups（P>0.05）. The FAS and PPS results of TCM symptoms improvement rate were 62.73% and 62.96% in the treatment group while those were 61.06% and 62.26% in the control group

showing no significant differences between groups（P>0.05）. Conclusion SJG is effective in treating children′s diarrhea with spleen deficiency pattern

showing the similar effect with Erbao Granules

and is safe.