Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing saw palmetto extracts Administration: Take one capsule with water between after dinner to before going to bed * Daily dose should be taken within
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. Subjects aged 50 or more 4. Healthy subjects 5. Subjects who are concern about frequency of urination 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose high sensitive prostate-specific antigen (PSA) value are less than 4 ng/mL at Scr at Scr 8. Subjects whose score of urinary urgency of overactive bladder symptom score (OABSS) are less than two or total score of OABSS are less than three 9. Subjects whose average daytime urinary frequency are eight and more and less than ten times in seven days before Scr 10. Subjects whose "frequent urination during the daytime hours" of "symptom bother" of OAB-q are relatively high
Exclusion criteria
Exclusion criteria: Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. plan to have surgery from first consumption to two weeks after last consumption 5. are undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria 6. wake up twice or more to urinate at bedtime 7. have overactive bladder symptom (subjects who urinate eight times or more per day, and have urinary urgency at least once a week) 8. 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)} 9. use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 10. are currently taking medications (including herbal medicines) and supplements 11. are allergic to medicines and/or the test food related products 12. are pregnant, breast-feeding, and planning to become pregnant 13. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of "frequent urination during the daytime hours" of "symptom bother" of Overactive Bladder questionnaire (OAB-q) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of "frequent urination during the daytime hours" of "symptom bother" of OAB-q between screening (before consumption: Scr) and 12w 2. The measured values and amount of change from Scr of "symptom bother", "the effect of QOL", "coping", "concern", "sleep", and "social interaction" of OAB-q at 12w 3-1*. The average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV 3-2*. The amout chande from period I of average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV 3-3*. The amout chande from period II of average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV *Period I: 7 days prior to Scr Period II: 7 days from 1 week prior to the start of intake to the day before the start of consumption Period III: 1st week of the start of consumption Period IV: 2nd week of the start of consumption Period V: 3rd week of the start of consumption Period VI: 4th week of the start of consumption Period VII: 5th week of the start of consumption Period VIII: 6th week of the start of consumption Period IX: 7th week of the start of consumption Period X: 8th week of the start of consumption Period XI: 9th week of the start of consumption Period XII: 10 weeks of the start of consumption Period XIII: 11th week of the start of consumption Period XIV: 12th week of the start of consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed