KCT0001867
Completed
未知
Human study for investigating the safety and effectiveness of lactium on the sleep quality : a randomized, double-blind, placebo-controlled, cross-over study
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Ewha Womans University Medical Center
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Participants who give informed consent before the start
- •2\) 20\~65 years, healthy men and women (men : women \= 1 : 1\)
- •3\) Subject with poor sleep quality (Pittsburgh Sleep Quality Index \> 5\)
Exclusion Criteria
- •1\) Subject with severe sleep disorder (Insomnia severity index \= 22\)
- •2\) Subject with snoring, sleep apnea, restless legs syndrome, periodic limb movement during sleep and narcolepsy
- •3\) Subject who has experienced excessive stress within 2 weeks prior to the first visit (death of spouse, family discord, immigration, etc.)
- •4\) Subject who took drugs that could have effect on sleeping within one month prior to the first visit
- •5\) Subject receiving hormone therapy
- •6\) Subject who consumes alcohol more than 140g per week (soju about 2\.5 bottles/week, about 2\.5 glasses/day)
- •7\) Excessive smoking (\> 20 cigarettes/day)
- •8\) Subject who consumes excessive caffeine (\> 10 cup of coffee/day)
- •9\) Night\-shift workers or subject who has irregular bedtime
- •10\) Subject who took extended trip to foreign country within 4 weeks prior to the first visit
Outcomes
Primary Outcomes
Not specified
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