Abstract:to investigate efficacy and safety of Huaji granules for treating children with functional abdominal pain. Methods: 430 children with functional abdominal pain were randomly assigned control group and Observation Group, control group took western medicine such as racemic hyoscyamine and domperidone, Observation Group received Huaji granule, compared efficacy and safety of two groups. Results: Observation group’s total effective rate (95.81%), was higher than control group (71.63%), Observation group’s TCM symptom scores (0.53±0.16) reduce more significantly than the control group (1.46±0.33). Observation Group had AE incidence of 1.39% lower than that of control group (17.21%) (P<0.05). Conclusion: Huaji Granules can treat children with functional abdominal pain by invigorating the spleen and stomach, regulating Qi and promoting digestion. It can alleviate clinical symptoms, control disease recurrence, therefore is recommended to be used in clinic.