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

RDC Clinical

Status and phase: Enrolling; Phase 4

Conditions: Lower Urinary Tract Symptoms

Treatments: Drug: Saw palmetto extract 320mg per day; Drug: Palm Oil capsule; Drug: Commercial Saw palmetto extract 320mg per day

Study type: Interventional

Funder types: Industry

Identifiers

NCT06266000

PROPAL

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Saw palmetto extract

Experimental group

Description:

Saw palmetto extract taken as 2 capsules per day

Treatment:

Drug: Saw palmetto extract 320mg per day

Comparator saw palmetto extract

Active Comparator group

Description:

Commercial saw palmetto extract taken as 2 capsules per day

Treatment:

Drug: Commercial Saw palmetto extract 320mg per day

Placebo

Placebo Comparator group

Description:

Palm oil taken as 2 capsules per day

Treatment:

Drug: Palm Oil capsule