Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saw palmetto extract | Experimental | Saw palmetto extract taken as 2 capsules per day |
|
| Comparator saw palmetto extract | Active Comparator | Commercial saw palmetto extract taken as 2 capsules per day |
|
| Placebo | Placebo Comparator | Palm oil taken as 2 capsules per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saw palmetto extract 320mg per day | Drug | Saw palmetto extract 160mg per capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Urinary Frequency Log | Change from baseline to the end of the study period in Daily Urinary Frequency Diary | Baseline for 7 days, Days 21-27, Day 49-55, Day 77-83 |
| 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. | Baseline, Day 28, Day 56, Day 84 |
| 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. | Baseline, Day 28, Day 56, Day 84 |
| International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amanda Rao, PhD | RDC Clinical Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Brisbane | Queensland | 4006 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Commercial Saw palmetto extract 320mg per day |
| Drug |
Saw palmetto extract 160mg per capsule |
|
| Palm Oil capsule | Drug | Palm oil capsule |
|
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. |
| Baseline, 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. | Baseline, 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. | Baseline, Day 84 |
| Inflammatory marker - JM27 | Change from baseline to the end of the study period in Inflammatory marker - JM27 assessed via blood test | Baseline, Day 84 |
| Blood pressure | Change from baseline to the end of the study period in blood pressure | Baseline, Day 84 |
| Pulse rate | Change from baseline to the end of the study period in pulse rate | Baseline, 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 |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C040972 | saw palmetto extract |
| D000073878 | Palm Oil |
| ID | Term |
|---|---|
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided