To evaluate the efficacy and safety of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage.Methods:A total of 282 subjects who were selected from October 2012 to January 2014 in Dongfang Hospital affiliated to Beijing University of Chinese Medicine were randomly divided into experimental (high-dose) group，positive drug group，low-dose group and placebo group with a course of treatment of 15 days.Changes in National Institutes of Health Stroke Scale (NIHSS) score，modified Rankin Scale (mRS) score，Barthel index，the efficacy score of traditional Chinese medicine (TCM) syndromes，vital signs，and related laboratory examination of each group were observed.Moreover，adverse reactions were observed.Results:Compared with the positive drug group，low-dose group and placebo group，the efficacy score of NIHSS，mRS，Barthel，and the TCM syndromes in the experimental group improved (P<0.05).The experimental group had an advantage of TCM syndromes include paralysis of lower limb，skew of tongue and mouth，stiff tongue，dysphasia and aphasia，hemianesthesia，headache，dizziness，oral dark purple (P<0.05).The incidence of adverse reactions showed no statistical differences among each group.Conclusion:Application of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage presents certain efficacy and high safety.