AIM To observe the effects of Qiwei Baizhu Powder (QWBZP) on rotaviral gastroenteritis in children and in animal models.METHODS Enrolled patients were divided into two groups, and one group was treated with oral rehydration solution (ORS) and the other treat ed with oral liquid of QWBZP. Neonate mice were orally infected with 50 µ µ µ µ µL rotavirus suspension (4×10 8 PFU/mL) and treated with ORS or oral liquid of QWBZP, respectively.RESULTS Eighty-three cases of rotaviral gastroenteritis treated with QWBZP revealed a better efficacy than that treated with ORS (χ χ χ χ χ 2 = 10.87, P<0.05). The contents of sodium and glucose as well as number of patients with positive human rotavirus antigen in stool in QWBZP group were all less than that in ORS group. In a nimal models, QWBZP was found effective in treating rotavirus gastroenteritis in neonate NIH mice, as compared with control groups. In QWBZP group, the mortality of infected mice was decreased by 73.3%, the body weight of infected mice was increased, the contents of sodium and glucose as well as number of mice with positive rotavirus antigen in feces were significantly reduced, and the pathological changes such as damage of small intestinal mucosa and villi were also obviously alleviated.CONCLUSION QWBZP has effects on improving the absorptive function of small intestine, shortening the duration of diarrhea and rotavirus shedding from stool and alleviating the pathological changes of small intestine induced by rotavirus.Subject headings gastroenteritis/drug therapy; rotavirus infections/drug therapy; Qiwei baizhu powder/therapeutic use; disease models, animal