Abstract： Objective： To discuss the clinical effect and mechanism of Shenxiong Zhengtan Pills on ischemic stroke from the perspectives of inflammatory responses and oxidative stress. Methods：A total of 83 cases of patients with acute ischemic stroke (blood stasis obstruction type) were selected as the study subjects and randomly divided into two groups. The control group (41 cases) received routine western medicine treatment， and the treatment group (42 cases) received routine western medicine treatment combined with Shenxiong Zhengtan Pills. Both groups were treated for 2 weeks. The clinical effects， traditional Chinese medicine (TCM) syndrome effects， coagulation function， oxidative stress， and inflammatory factor levels were compared between the two groups，and adverse reactions were recorded. Results： During the study， one case was dropped out from the treatment group， and 41 cases were ultimately included in the two groups respectively. After treatment，the clinical effect in the treatment group was significantly higher than that in the control group，the difference being significant (P＜0.05). There was no significant difference being found in the comparison of total clincial effective rates between the two groups (P＞0.05). The total effective rate of TCM syndromes in the treatment group was higher than that in the control group， the difference being significant (P＜0.05). After treatment， the levels of nuclear factor κB (NF- κB)，tumor necrosis factor- α (TNF- α) and interleukin-6 (IL-6) were decreased when compared with those before treatment， and the levels in the treatment group were lower than those in the control group， differences being significant (P＜0.05). The levels of superoxide dismutase (SOD)， prothrombin time (PT)， and activated partial thromboplastin time (APTT) in the two groups were increased when compared with those before treatment， and the levels of reactive oxygen species (ROS) and fibrinogen (FIB) were decreased when compared with those before treatment；the levels of SOD，PT，and APTT in the treatment group were higher than those in the control group， and the levels of ROS and FIB in the treatment group were lower than those in the control group， differences being significant (P＜0.05). The total incidence of adverse reactions was 12.20% in the control group，and 9.76% in the treatment group， there being no significance in the difference (P＞0.05). Conclusion：Shenxiong Zhengtan Pills can improve blood hypercoagulability，prevent neurological deterioration after cerebral ischemia，and has definite clinical effects without increasing the risk of adverse reactions. The mechanism of the curative effect of Shenxiong Zhengtan Pills may be related to inhibiting inflammatory responses and improving oxidative stress.