Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA
NCT ID: NCT04857021
Last Updated: 2021-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-04-14
2021-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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GABA
Take GABA capsule once daily before sleep for 14 days.
GABA
oral administration of GABA capsule once daily before sleep
Placebo
Take placebo capsule once daily before sleep for 14 days.
Placebo
oral administration of placebo capsule once daily before sleep
Interventions
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GABA
oral administration of GABA capsule once daily before sleep
Placebo
oral administration of placebo capsule once daily before sleep
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Who is experiencing mild, transient sleep disturbance (pittsburgh sleep quality index ≥ 5, Insomnia Severity Index ≥ 8)
* Who voluntarily agreed to participate in the study and signed an informed consent form.
Exclusion Criteria
* Who has used sleeping pills or sleep related dietary supplements within 4 weeks before study participation
* Who is suffering from obstructive sleep apnea.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.
19 Years
ALL
Yes
Sponsors
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Amorepacific Corporation
INDUSTRY
Responsible Party
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Locations
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Kyunghee University Hospital at Gangdong
Seoul, , South Korea
Countries
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Other Identifiers
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AP-PV-2018-01
Identifier Type: -
Identifier Source: org_study_id
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