Human study for investigating the safety and effectiveness of lactium on the sleep quality : a randomized, double-blind, placebo-controlled, cross-over study

Ewha Womans University Medical Center0 个研究点目标入组 48 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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
•11) Body mass index(BMI) = 18 kg/m2 or = 35 kg/m2
•12) Subjects who consumed functional foods or oriental medicine within one month prior to first visit
•13) Subject sensitive to experimental materials or dairy products
•14) Subject who participated in other human studies within one month prior to first visit
•15) Pregnant or lactating women
•16) Subject unable to use smartphone
•17) Any condition that the principal investigator believes may put the subject at undue risk

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