Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms

A Study to Compare 2 Extracts of Saw Palmetto Versus Placebo on the Symptoms of Beni

A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on the symptoms of benign prostate hyperplasia (BPH) in 120 generally healthy participants, 45 - 80 years.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Saw palmetto extract 320mg per day; Drug: Commercial Saw palmetto extract 320mg per day; Drug: Palm Oil capsule

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amanda Rao, PhD; Phone Number: +61 414 488 559; Email: amanda@rdcglobal.com.au
• Study Contact Backup: Name: David Briskey, PhD; Phone Number: +61 421 784 077; Email: david@rdcglobal.com.au

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Recruiting
      • RDC Clinical Pty Ltd
      • Contact: Amanda Rao, PhD; Phone Number: +61 414 488 559; Email: amanda@rdcglobal.com.au
      • Contact: David Briskey, PhD; Phone Number: +61 421 784 077; Email: david@rdcglobal.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male aged between 45-80
• Medically diagnosed with BPH (Participant to provide written evidence of medical diagnosis)
• Score of 12-19 in the IPSS (moderate)
• 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 BPH 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saw palmetto extract; Saw palmetto extract taken as 2 capsules per day	Drug: Saw palmetto extract 320mg per day; Saw palmetto extract 160mg per capsule
Active Comparator: Comparator saw palmetto extract; Commercial saw palmetto extract taken as 2 capsules per day	Drug: Commercial Saw palmetto extract 320mg per day; Saw palmetto extract 160mg per capsule
Placebo Comparator: Placebo; Palm oil taken as 2 capsules per day	Drug: Palm Oil capsule; Palm oil capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0, Day 28, Day 56, Day 84
Daily Urinary Frequency Diary	Change from baseline to the end of the study period in Daily Urinary Frequency Diary	Day 0, Days 21-27, Day 49-55, Day 77-83

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0, 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.	Day 0, 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.	Day 0, 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.	Day 0, Day 84
Inflammatory marker - JM27	Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test	Day 0, Day 84
Blood pressure	Change from baseline to the end of the study period in blood pressure	Day 0, Day 84
Pulse rate	Change from baseline to the end of the study period in pulse rate	Day 0, Day 84
Adverse event frequency	Change in safety as assessed by adverse events frequency	During enrolment period
Adverse event severity	Change in safety as assessed by adverse events severity	During enrolment period
Discontinuation due to adverse events	Number of participants who discontinue study due to adverse events.	During enrolment period

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 11, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Urological Agents; Saw palmetto extract
• Other Study ID Numbers: PROPAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No