Human study to evaluate the efficacy and safety of FSD-LS on sleep improvement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008197

Enrollment

100

Registered

2023-02-16

Start date

2023-02-20

Completion date

Unknown

Last updated

2025-04-07

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 : 4-week intake of FSD-LS

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Sleep health questionnaire;Sleep habits(Actigraphy, Sleep diary, Polysomnography)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactEunji Ha

Ewha Womans University

eunji.i.ha@gmail.com+82-2-3277-6556

Outcome results