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Completed

NCT Number: NCT06266000

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

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saw palmetto extract 320mg per day

Drug

Saw palmetto extract 160mg per capsule

Commercial Saw palmetto extract 320mg per day

Drug

Saw palmetto extract 160mg per capsule

Palm Oil capsule

Drug

Palm oil capsule

Primary outcomes

  1. Daily Urinary Frequency Log

    Time frame: 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

  2. International Prostate Symptom Score (IPSS)

    Time frame: 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 outcomes

  1. Brief Sexual Function Inventory (BSFI)

    Time frame: 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.

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

    Time frame: 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.

  3. Electrolytes (E/LFT) blood test

    Time frame: Baseline, Day 84

    Change from baseline to the end of the study period in electrolytes measured via E/LFT blood test.

  4. Liver Function (E/LFT) blood test

    Time frame: Baseline, Day 84

    Change from baseline to the end of the study period in liver function measured via E/LFT blood test.

  5. Inflammatory marker - JM27

    Time frame: Baseline, Day 84

    Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test

  6. Blood pressure

    Time frame: Baseline, Day 84

    Change from baseline to the end of the study period in blood pressure

  7. Pulse rate

    Time frame: Baseline, Day 84

    Change from baseline to the end of the study period in pulse rate

  8. Adverse event frequency

    Time frame: During enrolment period

    Change in safety as assessed by adverse events frequency

  9. Adverse event severity

    Time frame: During enrolment period

    Change in safety as assessed by adverse events severity

  10. Discontinuation due to adverse events

    Time frame: During enrolment period

    Number of participants who discontinue study due to adverse events.

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study title

A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on Lower Urinary Tract Symptoms (LUTS) and Urinary Frequency

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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