Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test product: Tablet containing 120 mg cranberry phospholipids Administration: Two tablets/day
Duration: Eight weeks Test product: Placebo Administration: Two tablets/day
Sponsors
Indena S.p.A. Medical Department at Product Portfolio Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals with positive urine leukocytes at Scr 6. Individuals whose score of urinary urgency of overactive bladder symptom score (OABSS) is less than two or total score of OABSS is less than three at Scr 7. Individuals whose "frequent urination during the daytime hours" of "symptom bother" of OAB-q is relatively high at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals carrying a pacemaker or an implantable cardioverter defibrillator 3. Individuals 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. Individuals who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily diet 5. Individuals currently regularly taking medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test-product-related products in this trial 7. Individuals with urinary pain 8. Individuals 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 9. Individuals have overactive bladder symptom (individuals who urinate eight times or more per day, and have urinary urgency at least once a week) 10. Individuals wake up twice or more to urinate at bedtime 11. Individuals are pregnant, breast-feeding, and planning to become pregnant 12. Individuals 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 13. Individuals are judged as ineligible to participate in the trial by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" after the 8-week intervention (8 w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individuals whose the response to the OAB-q questionnaire item "frequent urination during the daytime hours" improved by one or more scale points at 8w compared to screening (Scr) 2. The amount of change, and percentage of change from Scr for the OAB-q questionnaire item "frequent urination during the daytime hours" at 8w 3. The measured values, amount of changes, and percentage of changes from Scr for the OAB-q questionnaire items "Symptom Bother," "Coping," "Concern," "Sleep," "Social Interaction," "Impact on QOL," and all other questionnaire items, excluding "frequent urination during the daytime hours," at 8w 4. The measured values, and amount of changes and percentage of changes from Period 1 for the average frequency of urination during the daytime, during the nighttime, and all day, as measured during Periods 2 to 9 *Period 1: 7 days prior to Scr Period 2~9: Periods separated by 7 days from the start of intervention 5. Individuals who experienced adverse events 6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 7. Physical examination, urinalysis, and peripheral blood examination | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed