Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing ripened Korean red ginseng extract Administration: Take two tablets per day with water before going to bed. *If you forget to take the test food, t
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Subjects who are anxious about their sleep quality 3. Subjects who are judged as eligible to participate in the study by the principal investigator 4. Subjects who have a relatively lower average score of each item of OSA-MA at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are currently undergoing treatment of insomnia or sleep disorder 5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 6. Subjects who are currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products 8. Subjects who live with their infants less than one year old 9. Subjects who co-sleep with their children (one to six years old) 10. Subjects who live with requiring long-term care persons 11. Subjects who share the bed with more than one person 12. Subjects who work late-night shift and the life-styles are irregular 13. Subjects whose dinner time is extremely irregular 14. Subjects who have nocturia three times or more 15. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 16. Subjects who pregnant, breast-feeding, and planning to become pregnant 17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 18. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value and changes from screening (Scr) of "sleepiness on rising" at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value and changes from Scr of the following items at 12w: "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item of OSA sleep inventory MA version (OSA-MA) 2. The measured value and changes from Scr of each item of sleep test every one week after the start of test-food consumption 3. The measured values of original questionnaires (The Likert scale method) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed