OBJECTIVE: To investigate the safety and efficacy of Huatan Jieyu granules in treatment of Parkinson's disease(PD) patients with sleep disorder identified as symptom pattern of phlegma-heat-stirring wind in terms of the theory of Traditional Chinese Medicine.METHODS: In total, 107 Parkinson's disease patients with sleep disorders identified as symptom pattern of phlegma-heat-stirring wind were selected and randomly divided into the experimental group(55 cases) and the control group(52 cases).Both groups were given basic treatment with prednisone. The experimental group of patients was treated with Huatan Jieyu granules and the control group of patents was treated with only the basic treatment. Treatment lasted for 4 weeks. Sleep polygraph were recorded before the study as well as 3 months and 6 months after treatment.RESULTS: After treated with Huatan Jieyu granules,the total sleep time, and the percentage of non rapid eye movement 2(NREM 2), non rapid eye movement 3(NREM 3) and rapid eye movement(REM)sleep period increased significantly, while the percentage of NREM1 sleep period decreased significantly compared with before treatment(P < 0.05).CONCLUSION: The treatment of PD patients with sleep disorder by Huatan Jieyu granules can improve their sleep structure and their sleep quality.