Healthy human
Conditions
Interventions
Duration: 12 weeks Test material: Saw palmetto extracts containing capsule B Dose: Take a capsule once a day Administration: Swallow a capsule after breakfast with water or warm water (approximate
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese men who are 40 or more to less than 70 years old 2. Those who wake up for urination at least twice during nocturnal sleep 3. Those who have problems with urination, e.g. urinary urgency, frequent urination, and urinary incontinence 4. Those who are considered as appropriate for the study by the principal investigator 5. Those whose high-sensitivity PSA level is less than 3.0 ng/mL (40-65 years old) or less than 3.5 ng/ml (65-70 years old) at screening and examination before ingestion 6. Those who get less than 20 in score of IPSS at screening and examination before ingestion and do not need the treatment 7. If number of people who passed 6. exceed the sample size, select those who have relatively high score in 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. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder and urolithiasis 4. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 5. Currently taking medicines and/or herbal medicines 6. Those who are allergic to medicines and/or the test food related products 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others consider as inappropriate for this test by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS) *Assess at 0, 4, 8 and 12 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. King' s Health Questionnaire (KHQ) 2. Overactive Bladder Symptom Score (OABSS) 3. Subjective symptoms 3-1. Visual Analogue Scale (VAS) Pleasantness of waking, Sleep quality 3-2. Diary A frequency of urination per day, A frequency of urination at night 3-3. Interview sheet Time required for urination *1,2 Assess at 0, 4, 8 and 12 weeks after consuming *3-2 Keep it from a week before consuming to 12 weeks after consuming *3-1,3-3 Assess at 0 and 12 weeks after consuming | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed