Randomized, placebo-controlled, double-blind, clinical study to evaluate the sleep enhancing and improving effects and safety of Ecklonia Cava ethanolic extracts and Oryza Sativa L. ethanolic extracts

Randomized, Placebo-controlled, Double-blind, Clinical Study to Evaluate the Sleep Enhancing and Improving Effects and Safety of Ecklonia Cava Ethanolic Extracts and Oryza Sativa L. Ethanolic Extracts

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001892

Enrollment

Registered

2016-04-21

Start date

2013-04-01

Completion date

Unknown

Last updated

2019-03-11

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 : Subjects were randomly allocated to placebo group or test group. Each group takes placebo or Ecklonia Cava ethanolic extracts for 7 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. routine difficulty falling asleep, 2. frequent waking (=2 times) during the night 3. awaking in the morning feeling tired

Exclusion criteria

Exclusion criteria: 1. sleep disorders (e.g., sleep apnea, restless legs syndrome, periodic limb movements in sleep) or severe self-reported insomnia 2. shift work or unstable sleep schedule 3. trans-meridian travel (=3 time zones) within the past four weeks 4. body mass index (BMI) =32kg/m2 or =18 kg/m2 5. cognitive impairment 6. current use of sleep medications 7. excessive use of alcohol (=3 drinks/day or =6 drinks/week) and caffeine (=3 caffeinated drinks/day) 8. medical or psychiatric condition that would cause sleep disturbance 9. current severe insomnia

Design outcomes

Primary

Measure	Time frame
Sleep quality assessed by the polysomnography. The primary endpoint for this study is the determination of sleep quality, as assessed objectively with polysomnography, which is based on EEG/EMG (electromyography). The sleep patterns of the participants after ingestion of the test products will be compared to placebo.;Pittsburgh sleep quality index(PSQI)	—

Secondary

Measure	Time frame
Stanford sleepiness scale(SSS);Epworth sleepiness scale(ESS);Stress(BEPSI);Chronic fatigue syndrom	—

Countries

Korea, Republic of

Contacts

Public ContactJungi Kim

Seoul Sleep Center

Outcome results