OBJECTIVE：To observe the efficacy and safety of Xingnaojing injection in the treatment of ischemic stroke. METHODS： 110 patients with ischemic stroke were randomly divided into control group and observation group. 2 groups were given regulation of blood pressure and blood glucose， lipid lowering， aspirin， citicoline and edaravone， mannitol depending on severity and other conventional treatment. Based on it， control group was intravenously infused 250 ml 0.9％ Sodium chloride injection， once a day； observation group was additionally intravenously infused 20 ml Xingnaojing injection， adding into 250 ml 0.9％ Sodium chloride injection， once a day. The efficacy was judged after 14 d. US National Institutes of Health Stroke Scale （NIHSS） ， Glasgow coma score （GCS）， nitric oxide （NO）， nitric oxide synthase （NOS）， inducible nitric oxide （iNOS） content in 2 groups were observed， and in the incidence of adverse reactions was recorded. RESULTS： The total effective rat in observation group was significantly higher than control group， the difference was statistically significant （P＜0.05）. Before treatment， there were no significant differences in the NIHSS， NO， NOS and iNOS contents between 2 groups（P＞0.05）； after treatment， GCS in 2 groups were significantly higher than before， and observation group was higher than control group， NIHSS， NO， NOS and iNOS contents were significantly lower than before， and observation group was lower than control group， the differences were statistically significant（P＜0.05）. And there was no significant difference in the incidence of adverse reactions between 2 groups（P＞0.05）. CONCLUSIONS： Based on conventional treatment， Xingnaojing injection has significant efficacy in the treatment of ischemic stroke， with good safety， which may be related that it can reduce NO and GCS.