BACKGROUND: Vascular dementia (VaD) is the second common subtype of dementia after Alzheimer’s disease. However, there is still a lack of medication that demonstrates clinically relevant symptomatic improvement. Static blood obstructing the brain is the main Chinese medicine syndrome of VaD.OBJECTIVE: To evaluate the effects of Chinese medicine for promoting blood circulation and removing blood stasis in patients with mild to moderate VaD.DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: In this 12-week randomized, double-blind, parallel-controlled trial, a total of 48 patients with mild to moderate VaD were enrolled between March 2009 and December 2010. All the patients entered a two-week placebo run-in period followed by a 12-week treatment with Chinese medicine for promoting blood circulation and removing blood stasis (n=24) or placebo (n=24), respectively. The placebo tablets have the identical taste and appearance as the Chinese medicine tablets.MAIN OUTCOME MEASURES: The primary outcome measure was the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog); the secondary outcome measures included the Activities of Daily Living (ADL) and the Mini-Mental State Examination (MMSE).RESULTS: The Chinese medicine group showed a slight deterioration of 0.25 points and the placebo group showed a deterioration of 2.35 points from baseline by the ADAS-cog, and there was a significant difference between the two groups (P=0.027). The ADL and the MMSE showed no significant difference from baseline in both groups. Adverse events were rare in both groups.CONCLUSION: The Chinese medicine for promoting blood circulation and removing blood stasis may improve cognition and it is safe and well tolerated.