Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing saw palmetto Administration: Take one capsule per day before going to bed *If you forget to take the test food, take it as soon as you remember wi
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who feel a decline in quality of life due to urination issues 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose score of Questionnaire C of OABSS is less than 2 8. Subjects whose scores of physical limitations of KHQ are relatively low
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who need the treatment for diseases related to urination such as the overactive bladder, urolithiasis, and ureteral polyp 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 medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food-related products 8. Subjects who work late-night shift 9. Subjects who are pregnant, lactating, or planning to become pregnant 10. 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 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of the score of physical limitations of King's Health Questionnaire (KHQ) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the score of physical limitations of KHQ at four and eight weeks after consumption (4w, 8w) 2. The amount of change of the score of physical limitations of KHQ between screening (before consumption; Scr) and 4w, 8w, or 12w 3. The measured values and amounts of changes from Scr of the following items at 4w, 8w, and 12w: Nocturia quality of life questionnaire (N-QOL) overall score, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score, Pittsburgh Sleep Quality Index (PSQI) global score, and each domain score of KHQ (general health, incontinence impact, role limitations, social limitations, personal limitations, emotional problems, sleep/energy disturbance, and severity measures) 4. Daily fluid intake, the frequency of urination during the awake period, and the frequency of urination during nocturnal sleep every week after the start of test-food consumption 5. The measured values of the scores of the questionnaire (each item of N-QOL, ICIQ-SF, PSQI, and KHQ) at 4w, 8w, and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed