Status:
COMPLETED
Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA
Lead Sponsor:
Amorepacific Corporation
Conditions:
Sleep Disturbance
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.
Detailed Description
The subjects will take GABA or placebo capsule once daily before sleep for 14 days.
Eligibility Criteria
Inclusion
- Male and female subjects older than 19 years old
- 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
- Who is suffering from severe sleep disorder including sleep disorders due to psychological or neurologic causes.
- 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.
Key Trial Info
Start Date :
April 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04857021
Start Date
April 14 2019
End Date
June 15 2021
Last Update
September 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyunghee University Hospital at Gangdong
Seoul, South Korea