Objective: This study aimed to observe the clinical efficacy and safety of Bushen Huoxue Kaiqiao fang in the secondary prevention of the diabetes-induced vascular mild cognitive impairment (kidney deficiency and blood stasis). Method: Eighty-five cases of diabetes-induced vascular mild cognitive impairment were randomly divided into treatment group (43 cases) and control group (42 cases). The treatment group received the Bushen Huoxue Kaiqiao fang treatment three times a day orally and an oral administration of aspirin 100 mg once daily

while the control group were given oral administration of aspirin 100 mg once daily alone. The treatment continued for six months

every 6 months after the treatment there was a follow-up study till 12 months after the treatment.Daily living scale (ADL)

Montreal Cognitive Assessment Beijing Edition (MoCA)

P300 and traditional Chinese medicine(TCM) symptom scores were used for evaluation. Result: The variance analysis of repeated measurements analysis of variance revealed that

in both groups

the ADL scale

MoCA scale

P300 and TCM symptom score after treatment were all better than those before treatment at different periods

with the differencesstatistically significant (P<0.05). However

as for the comparison between treatment group and control group

there was no statistically significant difference in both sharply after the treatment and 6 months after the treatment

by t test of ADL scale

MoCA scale

P300 and TCM symptom rating scale scores;while the ADL scale

MoCA scale

P300 and TCM symptom rating scale scores of treatment group all showed statistically significant difference (P<0.01) between sharply after the treatment and 12 months after the treatment

compared with the control group. The incidence of adverse events in both groups showed no statistical significance by χ2 test. Conclusion: Bushen Huoxue Kaiqiao fang can only effectively prevent diabetes-induced vascular cognitive dysfunction continuing to develop

delaying its natural course of the disease

and can improve the patient's activities of daily living

cognitive function and clinical symptoms.