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

Phase 4

Recruiting

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Drug: Saw palmetto extract 320mg per day; Drug: Commercial Saw palmetto extract 320mg per day; Drug: Palm Oil capsule

• Registration Number: NCT06266000
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-11
• Study First Posted: 2024-02-20
• Study Start: 2024-06-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-05-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saw palmetto extract	Saw palmetto extract 320mg per day	Saw palmetto extract taken as 2 capsules per day
Comparator saw palmetto extract	Commercial Saw palmetto extract 320mg per day	Commercial saw palmetto extract taken as 2 capsules per day
Placebo	Palm Oil capsule	Palm oil taken as 2 capsules per day

Primary Outcome Measures

Name	Time	Method
Daily Urinary Frequency Log	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)	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.

Secondary Outcome Measures

Name	Time	Method
Liver Function (E/LFT) blood test	Baseline, Day 84	Change from baseline to the end of the study period in liver function measured via E/LFT blood test.
Inflammatory marker - JM27	Baseline, Day 84	Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test
Brief Sexual Function Inventory (BSFI)	Baseline, Day 28, Day 56, Day 84	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.
Electrolytes (E/LFT) blood test	Baseline, Day 84	Change from baseline to the end of the study period in electrolytes measured via E/LFT blood test.
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)	Baseline, Day 84	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.
Blood pressure	Baseline, Day 84	Change from baseline to the end of the study period in blood pressure
Pulse rate	Baseline, Day 84	Change from baseline to the end of the study period in pulse rate
Adverse event frequency	During enrolment period	Change in safety as assessed by adverse events frequency
Adverse event severity	During enrolment period	Change in safety as assessed by adverse events severity
Discontinuation due to adverse events	During enrolment period	Number of participants who discontinue study due to adverse events.

Trial Locations

Locations (1)

RDC Clinical Pty Ltd; 🇦🇺 Brisbane, Queensland, Australia