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Efficacy and Safety of Lime Peel Extract on Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Efficacy and Safety of Lime Peel Extract on Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009441
Enrollment
80
Registered
2024-05-17
Start date
2023-09-14
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : One hour before bedtime once a day, take a test group or a control group for two weeks. The test group is a lime and blood extract capsule formulation, and the control group is a

Sponsors

Nutra-it
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactEUN JI LIM

P&K Skin Research Center

ej.lim2@pnkskin.com+82-2-6925-1501

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026