Comparing two saw palmetto extracts for urinary symptoms
A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
This study is testing two different saw palmetto extracts to see if they can help men aged 45 to 80 with urinary problems compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06266000 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the effects of two different extracts of saw palmetto on lower urinary tract symptoms and urinary frequency. It will involve 120 generally healthy male participants aged 45 to 80 years, who will receive either one of the saw palmetto extracts or a placebo. Participants will be monitored for changes in their urinary symptoms over the course of the study. The trial aims to determine the efficacy of these extracts compared to a placebo in alleviating urinary issues.
Who should consider this trial
Good fit: Ideal candidates for this study are generally healthy males aged 45 to 80 with mild to moderate lower urinary tract symptoms.
Not a fit: Patients with serious or unstable illnesses, or those who have recently used treatments for urinary symptoms, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural treatment option for men suffering from lower urinary tract symptoms.
How similar studies have performed: While there have been studies on saw palmetto, this specific comparison of two extracts against a placebo is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male aged between 45-80 * Mild to moderate in the IPSS * 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 LUTS 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
Where this trial is running
Brisbane, Queensland
- RDC Clinical Pty Ltd — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Amanda Rao, PhD — RDC Clinical Pty Ltd
- Study coordinator: Amanda Rao, PhD
- Email: amanda@rdcglobal.com.au
- Phone: +61 414 488 559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.