Healthy adults
Conditions
Interventions
Test Food night 1 hour before bedtime 10 capsules/once Take it with water once a day, 1h before bedtime.
Pracebo food night 1 hour before bedtime 10 capsules/once Take it with water once a d
Sponsors
Shiba Palace Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese men and women aged 20 to 59 years old at the time of acquiring consent 2) Persons who have no drunk habit 3) Persons who are living a regular life (nearly constant sleeping time) 4) Healthy person 5) Persons who are not satisfied with sleeping (bad sleeping, nocturnal awakening, waking up is bad, etc.) 6) Persons who are aware of chronic fatigue
Exclusion criteria
Exclusion criteria: 1) Persons with mental disorders such as depression or those suspected of them 2) Persons who have experience in alcoholism, drug addiction or abuse 3) Persons who are taking or applying medicine (sleeping pill etc.) that seems likely to affect the examination result 4) Persons who regularly use antihistamines (for rhinitis, allergies etc.) currently, or those planning to use during the test period 5) Persons currently participating in other clinical trials 6) Persons who are in a profession with night work 7) Persons who are planning to travel domestically or overseas during the test period 8) Persons who can not consent to abstinence on the brain wave measurement day during the examination period 9) Persons who may have an allergy such as having a history of hypersensitivity to the test article 10) Persons with irregular life rhythms 11) During pregnancy or possibly pregnant, or those who are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood/Saliva test Watch pad (sleep survey) | — |
Countries
Japan
Contacts
Public ContactKou Masuda
SOUKEN Co., Ltd Management Division
Outcome results
None listed