Randomized, placebo-controlled, double-blind, clinical study to evaluate the sleep enhancing and improving effects and safety of Ecklonia Cava ethanolic extracts and Oryza Sativa L. ethanolic extracts
Not Applicable
Completed
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0001892
- Lead Sponsor
- Korea Food Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
1. routine difficulty falling asleep,
2. frequent waking (=2 times) during the night
3. awaking in the morning feeling tired
Exclusion Criteria
1. sleep disorders (e.g., sleep apnea, restless legs syndrome, periodic limb movements in sleep) or severe self-reported insomnia
2. shift work or unstable sleep schedule
3. trans-meridian travel (=3 time zones) within the past four weeks
4. body mass index (BMI) =32kg/m2 or =18 kg/m2
5. cognitive impairment
6. current use of sleep medications
7. excessive use of alcohol (=3 drinks/day or =6 drinks/week) and caffeine (=3 caffeinated drinks/day)
8. medical or psychiatric condition that would cause sleep disturbance
9. current severe insomnia
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep quality assessed by the polysomnography. The primary endpoint for this study is the determination of sleep quality, as assessed objectively with polysomnography, which is based on EEG/EMG (electromyography). The sleep patterns of the participants after ingestion of the test products will be compared to placebo.;Pittsburgh sleep quality index(PSQI)
- Secondary Outcome Measures
Name Time Method Stanford sleepiness scale(SSS);Epworth sleepiness scale(ESS);Stress(BEPSI);Chronic fatigue syndrom