Objective To observe the efficacy and safety of mildronate injection in treating acute cerebral infarction. Methods A randomized, double-blind, double-dummy, parallel-group, and multicenter clinical trial of mildronate injection was performed in 227 patients with acute cerebral infarction. These patients were divided into test group (n=113) and control group (n=114). The test group was given mildronate injection, while the control group was given cinepazide maleate injection. In addition, both groups were given Bayaspirin as basic treatment. After two weeks of treatment, the efficacy was evaluated using the National Institutes of Health Stroke Scale (NIHSS) and Barthel Index, and the safety was evaluated based on laboratory testing and adverse events. Results There were no significant differences in NIHSS score and Barthel Index score between the test group and control group (P>0.05). The two groups had similar incidence rate of adverse events (P>0.05). Conclusions Mildronate injection has comparable efficacy and safety to those of cinepazide maleate injection in treating acute cerebral infarction.