Comparison of 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency

NCT06266000 | Completed Phase 4

• 1 other identifier: PROPAL
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

• Daily Urinary Frequency Log

  Change from baseline to the end of the study period in Daily Urinary Frequency Diary

  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.

  Baseline, Day 28, Day 56, Day 84

Secondary Outcomes (10)

• Brief Sexual Function Inventory (BSFI)

  Baseline, Day 28, Day 56, Day 84

• International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)

  Baseline, Day 84

• Electrolytes (E/LFT) blood test

  Baseline, Day 84

• Liver Function (E/LFT) blood test

  Baseline, Day 84

• Inflammatory marker - JM27

  Baseline, Day 84

Study Arms (3)

Saw palmetto extract

EXPERIMENTAL

Saw palmetto extract taken as 2 capsules per day

Drug: Saw palmetto extract 320mg per day

Comparator saw palmetto extract

ACTIVE COMPARATOR

Commercial saw palmetto extract taken as 2 capsules per day

Drug: Commercial Saw palmetto extract 320mg per day

Placebo

PLACEBO COMPARATOR

Palm oil taken as 2 capsules per day

Drug: Palm Oil capsule

Interventions

Saw palmetto extract 320mg per day DRUG

Saw palmetto extract 160mg per capsule

Saw palmetto extract

Commercial Saw palmetto extract 320mg per day DRUG

Saw palmetto extract 160mg per capsule

Comparator saw palmetto extract

Palm Oil capsule DRUG

Palm oil capsule

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participated in any other clinical trial during the past 1 month

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

saw palmetto extract; Palm Oil

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: June 21, 2024
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: August 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)