A verification study on improvement of urination issues with ingestion of saw palmetto fruit extract: a randomized double-blind, parallel-group, placebo-controlled study
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000035036
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Sekikawa T, Kizawa Y, Li Y, Takara T. Verification study on the effects of saw palmetto fruit extract on urination issues: A randomized double-blind, parallel-group, placebo-controlled study. Jpn Pharmacol Ther. 2020; 48(3): 429-440
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 44
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method