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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2025-06-04

Brief Summary

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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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Detailed Description

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Saw palmetto extract

Saw palmetto extract taken as 2 capsules per day

Group Type EXPERIMENTAL

Saw palmetto extract 320mg per day

Intervention Type DRUG

Saw palmetto extract 160mg per capsule

Comparator saw palmetto extract

Commercial saw palmetto extract taken as 2 capsules per day

Group Type ACTIVE_COMPARATOR

Commercial Saw palmetto extract 320mg per day

Intervention Type DRUG

Saw palmetto extract 160mg per capsule

Placebo

Palm oil taken as 2 capsules per day

Group Type PLACEBO_COMPARATOR

Palm Oil capsule

Intervention Type DRUG

Palm oil capsule

Interventions

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Saw palmetto extract 320mg per day

Saw palmetto extract 160mg per capsule

Intervention Type DRUG

Commercial Saw palmetto extract 320mg per day

Saw palmetto extract 160mg per capsule

Intervention Type DRUG

Palm Oil capsule

Palm oil capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No