Abstract: AIM: To evaluate the effect and safety of Xiaoeryiniao Granule in the treatment of children with enuresis of kidney-qi deficiency. METHODS: A stratified-block randomized, double-blind, doubledummy, parallel-controlled, multicenter trial was designed for clinical study. RESULTS: In treating the syndrome of kidney-qi deficiency of enuresis, the clinical cure rates, the markedly effective rates and the total effective rates in the two groups were 26.33 % vs 21.30 %, 50.30 % vs 50.00 % and 76.63 % vs 71.30 %, respectively. By non-inferior test, the results suggested that the treatment group was non-inferior to the control group in clinical curative effect. Improvements of Chinese mealicine symptoms of two groups were as follows: cure rates, the markedly effective rates and the total effective rates were 20.71 % vs 16.67 %, 41.42 % vs 37.04 % and 62.13 % vs 53.71 % respectively, there was no significant difference between the two groups (P >0.05). But there were significant differences between pretreatment and post-treatment in intra-group comparison on single symptoms, such as times of enuresis, depth of sleep and abnormal tongue and pulse display. And two patients in the control group shown abnormal alanine aminotransferase(ALT) levels (aggravation after treatment with an occurance rate of 1. 75 %). CONCLUSION: Xiaoeryiniao Granules on children enuresis of kidney-qi deficiency not only non-inferior to the control group in clinical curative effect, but also has better safety.

Key words: Xiaoeryiniao Granule, enuresis, kidney-qi deficiency, therapy with TCM, clinical trail