actuca sativa L and Scutellaria baicalensis for sleep improvement
- Conditions
- Not Applicable
- Registration Number
- KCT0002821
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 86
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.
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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