Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

Amorepacific

Status

Completed

Conditions

Sleep Disturbance

Treatments

Dietary Supplement: GABA

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

AP-PV-2018-01

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.

Full description

The subjects will take GABA or placebo capsule once daily before sleep for 14 days.

Enrollment

60 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.