Lower Urinary Tract SymptomsPhase 4NCT06266000
Comparison of 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
A Phase 4 study testing Saw palmetto extract 320mg per day, Commercial Saw palmetto extract 320mg per day and Palm Oil capsule in people with Lower Urinary Tract Symptoms, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms and urinary frequency in 120 generally healthy participants, 45 - 80 years. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Saw palmetto extract 320mg per day, Commercial Saw palmetto extract 320mg per day and Palm Oil capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Jun 2024to 4 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms and urinary frequency in 120 generally healthy participants, 45 - 80 years.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Saw palmetto extract 320mg per day, Commercial Saw palmetto extract 320mg per day, Palm Oil capsule
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saw palmetto extract 320mg per dayDrug
Saw palmetto extract 160mg per capsule
Commercial Saw palmetto extract 320mg per dayDrug
Saw palmetto extract 160mg per capsule
Palm Oil capsuleDrug
Palm oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Saw palmetto extract | Experimental | Saw palmetto extract taken as 2 capsules per day Receives: Drug: Saw palmetto extract 320mg per day |
| Comparator saw palmetto extract | Active comparator | Commercial saw palmetto extract taken as 2 capsules per day Receives: Drug: Commercial Saw palmetto extract 320mg per day |
| Placebo | Placebo comparator | Palm oil taken as 2 capsules per day Receives: Drug: Palm Oil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Urinary Frequency Log
Change from baseline to the end of the study period in Daily Urinary Frequency Diary
Measured: Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83
International Prostate Symptom Score (IPSS)
Change from baseline to the end of the study period in the International Prostate Symptom Score (IPSS).The total score can range from 0 to 35 i.e. asymptomatic to very symptomatic.
Measured: Baseline, Day 28, Day 56, Day 84
Secondary outcomes (10)
Brief Sexual Function Inventory (BSFI)
Change from baseline to the end of the study period in Brief Sexual Function Inventory (BSFI). The total score can range from 0 to 44 with higher scores indicating better outcomes.
Measured: Baseline, Day 28, Day 56, Day 84
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Change from baseline to the end of the study period in International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS). The total score can range from 1 to 84 with higher scores indicating worse outcomes.
Measured: Baseline, Day 84
Electrolytes (E/LFT) blood test
Change from baseline to the end of the study period in electrolytes measured via E/LFT blood test.
Measured: Baseline, Day 84
Liver Function (E/LFT) blood test
Change from baseline to the end of the study period in liver function measured via E/LFT blood test.
Measured: Baseline, Day 84
Inflammatory marker - JM27
Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test
Measured: Baseline, Day 84
Blood pressure
Change from baseline to the end of the study period in blood pressure
Measured: Baseline, Day 84
Pulse rate
Change from baseline to the end of the study period in pulse rate
Measured: Baseline, Day 84
Adverse event frequency
Change in safety as assessed by adverse events frequency
Measured: During enrolment period
Adverse event severity
Change in safety as assessed by adverse events severity
Measured: During enrolment period
Discontinuation due to adverse events
Number of participants who discontinue study due to adverse events.
Measured: During enrolment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start21 Jun 2024
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266000
- Sponsor's protocol ID
- PROPAL
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
- ClinicalTrials.gov ID
- NCT06266000
- Acronym / sponsor ID
- PROPAL
- Conditions
- Lower Urinary Tract Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms and urinary frequency in 120 generally healthy participants, 45 - 80 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saw palmetto extract | Experimental | Drug: Saw palmetto extract 320mg per daySaw palmetto extract taken as 2 capsules per day |
| Comparator saw palmetto extract | Active comparator | Drug: Commercial Saw palmetto extract 320mg per dayCommercial saw palmetto extract taken as 2 capsules per day |
| Placebo | Placebo comparator | Drug: Palm Oil capsulePalm oil taken as 2 capsules per day |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saw palmetto extract 320mg per daySaw palmetto extract 160mg per capsule | Drug | Saw palmetto extract |
| Commercial Saw palmetto extract 320mg per daySaw palmetto extract 160mg per capsule | Drug | Comparator saw palmetto extract |
| Palm Oil capsulePalm oil capsule | Drug | Placebo |
Primary outcome
Daily Urinary Frequency Log
Time frame: Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83
Change from baseline to the end of the study period in Daily Urinary Frequency Diary
International Prostate Symptom Score (IPSS)
Time frame: Baseline, Day 28, Day 56, Day 84
Change from baseline to the end of the study period in the International Prostate Symptom Score (IPSS).The total score can range from 0 to 35 i.e. asymptomatic to very symptomatic.
10 secondary outcomes
Brief Sexual Function Inventory (BSFI)
Time frame: Baseline, Day 28, Day 56, Day 84
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Time frame: Baseline, Day 84
Electrolytes (E/LFT) blood test
Time frame: Baseline, Day 84
Liver Function (E/LFT) blood test
Time frame: Baseline, Day 84
Inflammatory marker - JM27
Time frame: Baseline, Day 84
Blood pressure
Time frame: Baseline, Day 84
Pulse rate
Time frame: Baseline, Day 84
Adverse event frequency
Time frame: During enrolment period
Adverse event severity
Time frame: During enrolment period
Discontinuation due to adverse events
Time frame: During enrolment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saw palmetto extract 320mg per day, Commercial Saw palmetto extract 320mg per day and Palm Oil capsule in people with Lower Urinary Tract Symptoms, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Urinary Frequency Log (time frame: Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.