Clinical trial NCT06266000: Comparison of 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
Official title: A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 120
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Daily Urinary Frequency Log
timeFrame: Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83
measure: International Prostate Symptom Score (IPSS)
timeFrame: Baseline, Day 28, Day 56, Day 84
Secondary outcomes:
measure: Brief Sexual Function Inventory (BSFI)
timeFrame: Baseline, Day 28, Day 56, Day 84
measure: International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS)
timeFrame: Baseline, Day 84
measure: Electrolytes (E/LFT) blood test
timeFrame: Baseline, Day 84
measure: Liver Function (E/LFT) blood test
timeFrame: Baseline, Day 84
measure: Inflammatory marker - JM27
timeFrame: Baseline, Day 84
measure: Blood pressure
timeFrame: Baseline, Day 84
measure: Pulse rate
timeFrame: Baseline, Day 84
measure: Adverse event frequency
timeFrame: During enrolment period
measure: Adverse event severity
timeFrame: During enrolment period
measure: Discontinuation due to adverse events
timeFrame: During enrolment period
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: