Overview
A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on the symptoms of benign prostate hyperplasia (BPH) in 120 generally healthy participants, 45 - 80 years.
Eligibility
Inclusion Criteria:
- Male aged between 45-80
- Medically diagnosed with BPH (Participant to provide written evidence of medical diagnosis)
- Score of 12-19 in the IPSS (moderate)
- Generally healthy
- Able to provide informed consent
- Agree not to participate in another clinical trial while enrolled in this trial
- Agree not the change their diet or exercise while enrolled in this trial
Exclusion Criteria:
- Serious illness e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions (A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments)
- Unstable illness e.g., diabetes and thyroid gland dysfunction (An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity)
- Have used a drug/natural therapy for BPH or other urological symptoms within the last 30 days?
- Have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis
- Have had urogenital surgery within the last 6 months.
- Have had a bladder biopsy and/or cystoscopy and biopsy within the past 30 days.
- Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)
- Receiving/ prescribed Coumadin (Warfarin) or other anticoagulation therapy
- Diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
- Diagnosed cancer including prostatic cancer; if suspected by the investigator, refer for medical assessment
- Active smokers and/or nicotine or drug abuse
- Chronic alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in investigational, comparator or placebo formula
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Participated in any other clinical trial during the past 1 month
