Human study to evaluate the efficacy and safety of FSD-LS on sleep improvement
Not Applicable
Recruiting
- Conditions
- Not Applicable
- Registration Number
- KCT0008197
- Lead Sponsor
- Ewha Womens University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1) Those who agreed to participate in this study and signed a written informed consent
2) Adult men and women aged from 19 to under 65
3) Those with low sleep quality (PSQI > 5 points)
Exclusion Criteria
1) Cases with major depressive disorder, bipolar disorder, alcohol dependence, or schizophrenia that require treatment when evaluated with a structured tool
2) Those with severe sleep disorders (ISI = 22 points)
3) Those with extreme daytime sleepiness (ESS = 16 points)
4) Those who are being treated or need treatment for the following diseases that cause sleep disorders: sleep apnea, restless legs syndrome, periodic limb movement during sleep, narcolepsy, etc
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep health questionnaire;Sleep habits(Actigraphy, Sleep diary, Polysomnography)
- Secondary Outcome Measures
Name Time Method Multimodal brain magnetic resonance imaging data;Neuropsychological test (Cambridge neuropsychological test automated battery, paper and pencil test);Vital sign;Clinical laboratory test(blood, urine);Adverse event