Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test material: Capsule containing saw palmetto extract Dose: Take one capsule per day Administration: Swallow a capsule before sleeping with water (about 200 mL) and no chewing
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese men who are 40 or more years old 2. Those who have nocturia at least twice 3. Those who are considered as appropriate for the study by the principal investigator 4. Those whose high-sensitivity PSA level is less than 3.0 ng/mL (40-64 years old), less than 3.5 ng/mL (65-70 years old), or less than 4.0 ng/mL (more than 70 years old) at screening (before consumption) 5. Those who have 8-19 points in the IPSS at screening (before consumption) and do not need the treatment 6. Select those who have relatively high score in the IPSS
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Those who need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder, and urolithiasis 5. Those who use or take "Foods for Specified Health Uses" and "Foods with Function Claims" in daily 6. Currently taking medications (including herbal medicines) and dietary supplements 7. Those who are an allergic reaction to medications and/or the test food related products 8. Those 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 9. Other considerations as ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS) *Calculate the change between screening (before consumption) and 8 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. IPSS 2. Overactive Bladder Symptom Score (OABSS) 3. Original questionnaires (Likert scale) 4. Ultrasonography of the post-void residual volume of urine *1,2,3 Assess these at screening (before consumption) and 4 and 8 weeks after consuming *4 Assess at screening (before consumption) and 8 weeks after consuming | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed