The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.
Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life. Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD. A total of 60 patients with depression in PD will be randomized to each of the three arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
herb extracts,were received two times a day for 12 weeks without dose changing.
herb extracts, were received two times a day for 12 weeks without dose changing.
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.
Xuanwu Hospital
Beijing, China
RECRUITINGHamilton Depression Scale
Change of Hamilton Depression Scale score on week 12 from baseline.
Time frame: 12 weeks
the responder rate (defined as score reduction of HAMD-17>=50%)
Time frame: 12 weeks
the Geriatric Depression Scale
GDS-30
Time frame: 12 weeks
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