To systematically evaluate the efficacy and safety of Huatuo Zaizao Pills （HZP）in the treatment of ischemic stroke,and to provide a reference for clinical treatment.Methods:PubMed,Embase,Cochrane Library,CNKI and other databases were screened to screen the clinical randomized controlled trials of HZP in the treatment of ischemic stroke.The publication date of the literature was limited to the establishment of the database to December 14,2020.A total of 2 investigators independently screened the literature and extracted data with reference to the inclusion and exclusion criteria.The bias risk assessment tool provided by the Cochrane Collaboration was used to assess the quality of the included studies.According to the size of heterogeneity,we selected fixed or random effect models to summarize effect estimates.We generated a forest map to show the summary results.TSA0.9 was applied in test sequential analysis.Results:A total of 16 studies were included,including 1616 participants,827 in the experimental group,and 789 in the control group.Meta-analysis results showed that the Huatuo Zaizao Pills group improved the total effective rate of treatment ［OR=3.36,95%CI(2.43 to 4.56),P<0.001］ and reduced the NIHSS ［MD=-2.72,95%CI(-3.72 to -1.73),P<0.001］,improved daily function and living ability ［MD=8.89,95%CI(4.51 to 13.26),P<0.001］ better than the control group; only 6 studies have reported safety indicators.More research was needed to further clarify the safety of clinical medication.TSA results showed that the Huatuo Zaizao Pills group had better evidence for the treatment of ischemic stroke.Conclusion:Current research shows that HZP group can significantly improve the total effective rate of patients with ischemic stroke,reduce the stroke scale score,and improve daily functional life ability,but its safety needs to be further determined.Due to the low quality of the research methodology included in this study and the small sample size,further large-scale,high-quality studies are needed to verify its efficacy and safety.