Clinical trial for Comparative Study on the Effect of Intake of Lyme and Blood Extract on Improvement of Sleep Health and Safety(Random Allocation, Double Blindness, Control Comparison)

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1) men and women aged 19 to 65
2) Those with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher
3) A person who agrees to participate in this study and signs a written consent form

Exclusion Criteria

1) Those with extreme sleep disorders (Insomnia severity index = 22 points, or = 7 points factor)
2) Those who have the following conditions (including mental illness) that cause sleep disorders
: Sleep apnea (sleep apnea), restless leg syndrome, periodic limb movement disorder (periodic limb movement during sleep), depression, narcolepsy (dyspathy)
3) Changes that may cause excessive stress within 2 weeks of the first visit
: : Death of spouse, family feud, litigation/dispute, sudden difficulty in living, immigration, etc
4) Those who are taking medicines that may affect their sleep within one month of their first visit
5) A person undergoing hormone therapy
6) Those who usually drink too much alcohol (>280g/week, about 5 bottles/weeks of soju)
7) Those who smoke excessively (> 10 cigarettes/day)
8) Those who consume more than 400mg of caffeine daily (ex. those who consume 8 cups of mixed coffee, 3 cups of americano, and 8 cups of green tea or more)
9) A night shift worker or a person whose bedtime is irregular due to his/her usual job, etc
10) A person who has traveled long distances to a country with a different time difference within one month of his/her first visit
11) Body mass index (BMI) is 18kg/m2 or less or 35kg/m2 or more
12) A person who has continuously consumed health functional food or herbal medicine within one month of his/her first visit
13) A person who participated in a clinical trial within one month of the first visit
14) Pregnant women and nursing mothers
15) If the researcher deems it inappropriate to participate in this test

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep efficiency (SE), sleep incubation period (SL), total sleep time (TST), wake-up time (WASO), Delta power, Pittsburgh sleep quality assessment questionnaire (PSQI)

Secondary Outcome Measures

Name	Time	Method
Sleep journal questionnaire, Stanford Sleepiness Scale (SSS) questionnaire, daytime sleepiness scale (ESS) questionnaire, Korean version of the Perceived Stress Scale (PSS), weekly Resilient Sleep Score (RSQ-W) questionnaire, fatigue symptom scale (FSS), saliva cortisol