None listed
Conditions
Interventions
Dietary Supplement : Extract mixtures of Lactuca sativa L and Scutellaria baicalensis or placebo
3 capsules (750mg x 3) per day, 60 minutes before sleep, once a day for 4 to 6 weeks
Sponsors
Ewha Womans University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Diagnosed with insomnia assessed with a structured interview based on ICD-10 and the PSQI scores or classified as having severe sleep apnea or periodic limb movement symptoms based on the polysomnography results. - Current intake of medication known to induce sleep disorders (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 Lactuca sativa L and/or Scutellaria baicalensis, or had experienced side effects after consumption of any product containing Lactuca sativa L and/or Scutellaria baicalensis - 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;Chagne from baseline physical activity at 4 weeks assessed by actigraph;Change from baseline objective sleep quality at 4 weeks assessed by polysomnography | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery;Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale;Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale;Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data | — |
Countries
Korea, Republic of
Contacts
Public ContactJungyoon Kim
Ewha Womans University
Outcome results
None listed