Healthy Adults With Subjective Sleep Complaints Clinical Trial
Official title:
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
| Verified date | January 2018 |
| Source | Ewha Womans University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | December 31, 2017 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Ewha Womans University | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Ewha Womans University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index | Baseline and week 4 | ||
| Primary | Chagne from baseline physical activity at 4 weeks assessed by actigraph | Baseline and week 4 | ||
| Primary | Change from baseline objective sleep quality at 4 weeks assessed by polysomnography | Baseline and week 4 | ||
| Secondary | Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery | Baseline and week 4 | ||
| Secondary | 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.) |
Baseline and week 4 | |
| Secondary | 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 | |
| Secondary | Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data | Baseline and week 4 |