Healthy Japanese
Conditions
Interventions
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Duration>
Non-intervention: Four weeks Intervention: Four weeks <
t.CURE-14000 <
Use once a day for 60 minutes. *If you forget to use the test product, use it as soon as you remember. If you cannot be used, record it in the diary
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor or cardiovascular disease, such as heart failure, myocardial infarction, cardiac arrhythmia, or arteriosclerosis 2. have a pacemaker or an implantable cardioverter defibrillator 3. are currently undergoing treatment for any of the following chronic diseases: liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking medications (including herbal medicines) and supplements 6. are allergic to medications 7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 8. have irregular sleeping time or habit due to work such as a late-night shift 9. live with their infants less than one year old 10. sleep with their children (1 to 6 years old) 11. live with requiring long-term care persons 12. sleep with more than one person 13. have nocturia three times or more 14. are restricted from daily intense physical activity due to diseases or other reasons 15. use a wearable medical electrical equipment, such as an electrocardiograph 16. need to rest 17. have temperature sensory loss 18. have sleep apnea syndrome 19. are taking antithrombotic medicine or undergoing medical treatment for hematogenous disorder 20. may be jumped on or suddenly touched by people, objects or pets while using the test product 21. cannot use the test product with properly understanding the usage and precautions required to use it 22. are pregnant, lactating, or planning to become pregnant during this study 23. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 24. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sleep test after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length" and each item in the OSA sleep inventory MA version (OSA-MA) after intervention 2. The number of days with defecation, the defecation frequency, and the amount of defecation after intervention 3. Stool shape, stool color, stool smell, and exhilarating feeling of defecation after intervention 4. Body temperature upon waking after intervention | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed