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This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polygonatum sibiricum | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polygonatum sibiricum | Dietary Supplement | Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index | Baseline and week 4 | |
| Chagne from baseline physical activity at 4 weeks assessed by actigraph | Baseline and week 4 | |
| Change from baseline objective sleep quality at 4 weeks assessed by polysomnography | Baseline and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery | 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University | Seoul | 03759 | South Korea |
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| Placebo | Dietary Supplement | Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks |
|
| 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.) | Baseline and week 4 |
| Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data | Baseline and week 4 |