A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts: a randomized double-blind, parallel-group, placebo-controlled study
- Conditions
- Healthy human
- Registration Number
- JPRN-UMIN000027902
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International Prostate Symptom Score (IPSS) *Assess at 0, 4, 8 and 12 weeks after consuming
- Secondary Outcome Measures
Name Time Method 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