Lower Urinary Tract Symptoms
Conditions
Brief summary
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.
Interventions
DRUGSaw palmetto extract 320mg per day
Saw palmetto extract 160mg per capsule
DRUGCommercial Saw palmetto extract 320mg per day
Saw palmetto extract 160mg per capsule
DRUGPalm Oil capsule
Palm oil capsule
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Urinary Frequency Log | 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 |
| International Prostate Symptom Score (IPSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Electrolytes (E/LFT) blood test | Baseline, Day 84 | Change from baseline to the end of the study period in electrolytes measured via E/LFT blood test. |
| Liver Function (E/LFT) blood test | Baseline, Day 84 | Change from baseline to the end of the study period in liver function measured via E/LFT blood test. |
| Inflammatory marker - JM27 | Baseline, Day 84 | Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test |
| Blood pressure | Baseline, Day 84 | Change from baseline to the end of the study period in blood pressure |
| Brief Sexual Function Inventory (BSFI) | 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. |
| Adverse event frequency | During enrolment period | Change in safety as assessed by adverse events frequency |
| Adverse event severity | During enrolment period | Change in safety as assessed by adverse events severity |
| Discontinuation due to adverse events | During enrolment period | Number of participants who discontinue study due to adverse events. |
| Pulse rate | Baseline, Day 84 | Change from baseline to the end of the study period in pulse rate |
| International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) | 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. |
Countries
Australia
Outcome results
None listed