Japanese adults with healthy, insomnia, or chronic fatigue syndrome
Conditions
Interventions
Duration: 4 weeks Test materials: AFO MD Dose: 1 pack, twice a day Administration: Take the morning pack in the morning and take the evening pack in the evening. *Take the powder by mouth or the p
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adult men or 40-69 years old of post-menopausal women (naturally menopausal women) 2. Those who are healthy, feel sleeplessness, or feel fatigue or who were diagnosed with insomnia or chronic fatigue syndrome (excluded persons taking the medicine) 3. Those who were considered as appropriate for participation in this trial by the study responsible physician 4. Those who have a smaller area under the curve (AUC: area under the salivary cortisol concentration-time curve) between 8 a.m. and 8 p.m.
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history 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 or hypertension 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 smokers 7. Those who plan to take loxoprofen (such as Loxonin) during the intervention period 8. Currently visiting hospital for diseases other than insomnia and chronic fatigue syndrome 9. Those who had participated another clinical trial for three months when you signed the informed consent form for this trial 10. Others considered as inappropriate for the study by the study responsible physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Saliva test The concentration of salivary cortisol | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood test The concentration of serum DHEA-S (dehydroepiandrosterone sulfate), serum FT (free testosterone), and serum FT3 (free triiodothyronine) 2. Subjective symptoms Likert scale | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed