Human study to evaluate the efficacy and safety of CV212 on sleep improvement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010070

Enrollment

100

Registered

2024-12-20

Start date

2024-12-23

Completion date

Unknown

Last updated

2025-01-06

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 : Participants who voluntarily signed the informed consent form for the clinical trial during Visit 1 are evaluated for suitability based on inclusion and exclusion criteria. Partic

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

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 3) Those with extreme daytime sleepiness 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 (PSQI, AIS, ISI, PSAS, GSES, etc.);Sleep habits(Actigraphy, Sleep diary, Polysomnography)	—

Secondary

Measure	Time frame
Brain imaging;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 ContactChaewon Suh

Ewha Womens University

chaewon.ss.suh@ewha.ac.kr+82-2-3277-6556

Outcome results