This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks
Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks
Ewha Womans University
Seoul, South Korea
Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index
Time frame: Baseline and week 4
Chagne from baseline physical activity at 4 weeks assessed by actigraph
Time frame: Baseline and week 4
Change from baseline objective sleep quality at 4 weeks assessed by polysomnography
Time frame: Baseline and week 4
Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery
Time frame: Baseline and week 4
Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale
Scale name: Hamilton Depression Rating Scale / Range of total score: 0 - 52 (Higher scores represent more severe depressive symptoms.)
Time frame: Baseline and week 4
Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale
Scale name: Hamilton Anxiety Rating Scale / Range of total score: 0 - 56 (Higher scores represent more severe anxiety symptoms.)
Time frame: Baseline and week 4
Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data
Time frame: Baseline and week 4
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