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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06266000
Registration number
NCT06266000
Ethics application status
Date submitted
31/01/2024
Date registered
20/02/2024
Titles & IDs
Public title
Comparison of 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
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Scientific title
A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
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Secondary ID [1]
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PROPAL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lower Urinary Tract Symptoms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Saw palmetto extract 320mg per day
Treatment: Drugs - Commercial Saw palmetto extract 320mg per day
Treatment: Drugs - Palm Oil capsule
Experimental: Saw palmetto extract - Saw palmetto extract taken as 2 capsules per day
Active comparator: Comparator saw palmetto extract - Commercial saw palmetto extract taken as 2 capsules per day
Placebo comparator: Placebo - Palm oil taken as 2 capsules per day
Treatment: Drugs: Saw palmetto extract 320mg per day
Saw palmetto extract 160mg per capsule
Treatment: Drugs: Commercial Saw palmetto extract 320mg per day
Saw palmetto extract 160mg per capsule
Treatment: Drugs: Palm Oil capsule
Palm oil capsule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Daily Urinary Frequency Log
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Assessment method [1]
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Change from baseline to the end of the study period in Daily Urinary Frequency Diary
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Timepoint [1]
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Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83
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Primary outcome [2]
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International Prostate Symptom Score (IPSS)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Day 28, Day 56, Day 84
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Secondary outcome [1]
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Brief Sexual Function Inventory (BSFI)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Day 28, Day 56, Day 84
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Secondary outcome [2]
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International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Day 84
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Secondary outcome [3]
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Electrolytes (E/LFT) blood test
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Assessment method [3]
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Change from baseline to the end of the study period in electrolytes measured via E/LFT blood test.
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Timepoint [3]
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Baseline, Day 84
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Secondary outcome [4]
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Liver Function (E/LFT) blood test
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Assessment method [4]
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Change from baseline to the end of the study period in liver function measured via E/LFT blood test.
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Timepoint [4]
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Baseline, Day 84
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Secondary outcome [5]
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Inflammatory marker - JM27
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Assessment method [5]
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Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test
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Timepoint [5]
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Baseline, Day 84
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Secondary outcome [6]
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Blood pressure
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Assessment method [6]
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Change from baseline to the end of the study period in blood pressure
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Timepoint [6]
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Baseline, Day 84
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Secondary outcome [7]
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Pulse rate
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Assessment method [7]
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Change from baseline to the end of the study period in pulse rate
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Timepoint [7]
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Baseline, Day 84
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Secondary outcome [8]
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Adverse event frequency
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Assessment method [8]
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Change in safety as assessed by adverse events frequency
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Timepoint [8]
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During enrolment period
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Secondary outcome [9]
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Adverse event severity
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Assessment method [9]
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Change in safety as assessed by adverse events severity
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Timepoint [9]
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During enrolment period
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Secondary outcome [10]
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Discontinuation due to adverse events
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Assessment method [10]
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Number of participants who discontinue study due to adverse events.
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Timepoint [10]
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During enrolment period
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Eligibility
Key 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
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Minimum age
45
Years
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Maximum age
80
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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RDC Clinical Pty Ltd - Brisbane
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06266000
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amanda Rao, PhD
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Address
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RDC Clinical Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amanda Rao, PhD
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Address
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Country
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Phone
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+61 414 488 559
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06266000