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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266000
• Other study ID #: PROPAL
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Saw palmetto extract 320mg per day
Saw palmetto extract 160mg per capsule
• Commercial Saw palmetto extract 320mg per day
Saw palmetto extract 160mg per capsule
• Palm Oil capsule
Palm oil capsule

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure	Change from baseline to the end of the study period in blood pressure	Day 0, Day 84
Secondary	Pulse rate	Change from baseline to the end of the study period in pulse rate	Day 0, Day 84
Secondary	Adverse event frequency	Change in safety as assessed by adverse events frequency	During enrolment period
Secondary	Adverse event severity	Change in safety as assessed by adverse events severity	During enrolment period
Secondary	Discontinuation due to adverse events	Number of participants who discontinue study due to adverse events.	During enrolment period