Objectives To study the effects of Bushenhuoxue Granules on sleep quality of patients with parkinson’s disease.

Methods Totally 96 patients were enrolled and randomly divided into two groups, the control group were treated with placebo and treatment group with Bushenhuoxue Granules, both group based on Madopar treatment. A multi-centre, randomised, placebo-controlled, double-blind clinical study was adopted in treatment period. And follow-up period was for 6 months, Parkinson’s disease sleep scale (PDSS) was adopted to measure sleep quality of PD patients at baseline time, after 3 and 9 months.

Results Bushenhuoxue Granules treatment group showed a higher efficacy than the placebo group in relieving the sleep disorders of Parkinson disease patients, both in treatment and follow-up period (P<0.01). No adverse effects were found in this trial.

Conclusions Bushenhuoxue Granules can markedly improve sleep disorders in patients with parkinson’s disease.