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

RDC Clinical Pty Ltd89 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lower Urinary Tract Symptoms

Interventions

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

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

Daily Urinary Frequency Log

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

Time frame: 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.

Time frame: Baseline, Day 28, Day 56, Day 84

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Day 84

Data from ClinicalTrials.gov

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