Healthy adults
Conditions
Interventions
1. Take the active capsule for 1 week *Take 2 capsules with water or warm water 30 to 60 minutes before going to bed 2. After 1 week, take 2 active capsules with water or warm water 15 to 30 minu
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults who feel quality of sleep dissatisfaction 2. Within 1 and be employees 3. Those who are considered as appropriate for the study by the physician and are diagnosed insomnia 4. Within 3, those who have a relatively low score of OSA sleep inventory MA version at baseline
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome or other chronic diseases 3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines and/or herbal medicines 5. Those who are allergic to medicines and/or the test food related products 6. Those who are pregnant, breast-feeding, and plan to become a pregnant 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Those who live with infants (less than 1-year-old) 9. Those who sleep with children (1 to 6 years old) 10. Those who live with requiring long-term care persons 11. Those who sleep with more than one person in a bed 12. Those who work late-night shift and the life-styles are irregular 13. Body mass index (BMI) is more than 25 kg/m2 14. A frequency of urination is more than 8 times per day 15. Those who are susceptible to pollen allergy or are suffering from asthma 16. Those who have diarrhea with dairy products (including those diagnosed with lactose intolerance) 17. Others considered as inappropriate for the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. OSA sleep inventory MA version *Fill it in immediately after waking up at home on the examination day and two days before | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep Scan *Perform it at participant's home 1 week before each examination day 2. Uchida-Kreaepelin performance test *Perform on each examination day 3. Questionnaires of subjective symptoms a. Immediately on rising questionnaire * Fill it in immediately after waking up at home on the examination day and two days before b. Questionnaire when Uchida-Kreaepelin performance test *Fill in the questionnaire before, after, and break Uchida-Kreaepelin performance test | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed