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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06266000




Registration number
NCT06266000
Ethics application status
Date submitted
31/01/2024
Date registered
20/02/2024
Date last updated
4/04/2024

Titles & IDs
Public title
Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms
Scientific title
A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on the Symptoms of Beni
Secondary ID [1] 0 0
PROPAL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
International Prostate Symptom Score (IPSS)
Timepoint [1] 0 0
Day 0, Day 28, Day 56, Day 84
Primary outcome [2] 0 0
Daily Urinary Frequency Diary
Timepoint [2] 0 0
Day 0, Days 21-27, Day 49-55, Day 77-83
Secondary outcome [1] 0 0
Brief Sexual Function Inventory (BSFI)
Timepoint [1] 0 0
Day 0, Day 28, Day 56, Day 84
Secondary outcome [2] 0 0
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
Timepoint [2] 0 0
Day 0, Day 84
Secondary outcome [3] 0 0
Electrolytes (E/LFT) blood test
Timepoint [3] 0 0
Day 0, Day 84
Secondary outcome [4] 0 0
Liver Function (E/LFT) blood test
Timepoint [4] 0 0
Day 0, Day 84
Secondary outcome [5] 0 0
Inflammatory marker - JM27
Timepoint [5] 0 0
Day 0, Day 84
Secondary outcome [6] 0 0
Blood pressure
Timepoint [6] 0 0
Day 0, Day 84
Secondary outcome [7] 0 0
Pulse rate
Timepoint [7] 0 0
Day 0, Day 84
Secondary outcome [8] 0 0
Adverse event frequency
Timepoint [8] 0 0
During enrolment period
Secondary outcome [9] 0 0
Adverse event severity
Timepoint [9] 0 0
During enrolment period
Secondary outcome [10] 0 0
Discontinuation due to adverse events
Timepoint [10] 0 0
During enrolment period

Eligibility
Key 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
Minimum age
45 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06266000
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
amanda@rdcglobal.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06266000