A human study to evaluate the efficacy and safety of pollen extract G63® in men with lower urinary tract symptoms
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0007869
- Lead Sponsor
- Dankook Univeristy Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 120
1) A men who agreed to participate in this study and signed a written informed consent
2) A men aged from 40 to under 80
3) A men with lower urinary tract symptoms of mild to moderate lower urinary tract symptoms (IPSS of 1-19)
1) A men with prostate volume = 40mL
2) A men with serum PSA level =4 ng/mL
3) A men with peak flow rate < 5mL/s
4) A men with post-void residual urine = 150mL
5) A men who takes 5aRI, PDE-5 inhibitor, a-blocker, anticholinergics, beta-3 adrenergic agonist
6) A men who takes health functional foods which can affect prostate health within 1 month of first visit
7) A men with acute prostatitis, urinary tract infection, acute urinary retention, neurogenic bladder, prostate cancer or bladder cancer, etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS),residual urine volume, uroflometry ;NIH-chronic prostatitis symptom index (NIH-CPSI), International index of erectile function-5(IIEF-5), serum PSA
- Secondary Outcome Measures
Name Time Method Vital sign;Clinical laboratory test(blood, urine);Adverse event