Benign Prostatic Hyperplasia
Conditions
Keywords
prostate, dietary supplements, saw palmetto, canada
Brief summary
The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.
Interventions
DIETARY_SUPPLEMENTCombination of 2007RD01 and saw palmetto lipidic extract
Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
DIETARY_SUPPLEMENTSaw palmetto lipidic extract
Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
Sponsors
innoVactiv Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient must be an adult man aged between 50 and 75 * Patient must have Benign Prostatic Hyperplasia symptoms
Exclusion criteria
* Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection * Patient has been subjected to surgery of the prostate, bladder or urethra * Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening * Patient has taken an alpha-blocker in the 2-week period preceding screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute and relative (%) change in IPSS between baseline and end of study | 90 days ±7 days |
Secondary
| Measure | Time frame |
|---|---|
| Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up | 30 days ±7 days |
| Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
| Absolute and relative (%) change in post-void residual volume between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
| Change in health related quality of life between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
| Change in sexual function between baseline and after 30 or 90 days of follow-up | 30 days ±7 days , 90 days ±7 days |
Countries
Canada
Outcome results
None listed