OBJECTIVE： To observe the effects and safety of Congrong yishen granule combined with Donepezil hydrochloride tablet on mental state and quality of life in patients with Parkinson disease with dementia （PDD）. METHODS： A total of 60 PDD patients were randomized into control group and treatment group， with 30 cases in each group. Both groups were given drugs for Parkinson disease. Control group was additionally given Donepezil hydrochloride tablet 5 mg， qd； treatment group was additionally given Congrong yishen granules 2 g， bid， on the basis of control group. The treatment lasted for 6 months in both groups. MMSE， MoCA， ADAS-Cog， ADL-R and TCM symptom score were observed in 2 groups before and after treatment. The occurrence of ADR were compared between 2 groups. RESULTS： Before treatment， there was no statistical significance in MMSE， MoCA， ADAS-Cog， ADL-R or TCM symptom score between 2 groups （P＞0.05）. After treatment， MMSE and MoCA score of 2 groups were increased significantly， while ADAS-Cog， ADL-R and TCM symptom score were decreased significantly； the treatment group were better than the control group， with statistical significance （P＜0.05）. No obvious ADR was found in 2 groups. CONCLUSIONS： Congrong yishen granule combined with donepezil hydrochloride tablet can significantly improve mental state and cognitive ability of PDD patients， and relieve clinical symptoms with good safety.