Healthy Adults With Subjective Sleep Complaints
Conditions
Brief summary
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
Interventions
DIETARY_SUPPLEMENTPolygonatum sibiricum
Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female volunteers who are between the ages of 20 and 65 * Experienced any of the following sleep problems, at least more than once a week for more than 2 months: 1) difficulty in falling asleep or staying asleep; 2) waking up at dusk and not being able to fall asleep again; 3) not feeling refreshed even after getting some sleep.
Exclusion criteria
* Diagnosed with insomnia assessed with a structured interview and sleep scale measurements * Possibility of drug-induced sleep disorders due to current intake of medication (i.e., corticosteroid, statin, etc) * Had taken sleeping pills (i.e., zolpidem, benzodiazepine) during the past 2 months * Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests. * Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, alcohol dependence, schizophrenia) evaluated with a structured instrument * A history of traumatic brain injury with loss of consciousness, or any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in body) * Had taken psychotropic drugs within the past 3 months before study participation * Allergic to polygonatum sibiricum or experienced side effects after consumption of any product containing polygonatum sibiricum * Participated in another clinical trial or took other medications during the period that may influence the results of this clinical trial * Currently taking contraceptive pills * Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery | 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 | — |
| Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale | Baseline and week 4 | Scale name: Hamilton Depression Rating Scale / Range of total score: 0 - 52 (Higher scores represent more severe depressive symptoms.) |
| Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale | Baseline and week 4 | Scale name: Hamilton Anxiety Rating Scale / Range of total score: 0 - 56 (Higher scores represent more severe anxiety symptoms.) |
Countries
South Korea
Outcome results
None listed