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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.
This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (ProstaThrive™) | Experimental | Participants will take three capsules daily after the final meal of the day for 90 days. |
|
| Placebo | Placebo Comparator | Participants will take three placebo capsules daily after the final meal of the day for 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProstaThrive™ Supplement | Dietary Supplement | Participants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Urinary Tract Symptoms (LUTS) | Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS). | Baseline, Day 30, Day 60, and Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Function and Performance | Measured by the ability to get and maintain an erection at Baseline, Day 30, Day 60, and Day 90 via study-specific questionnaires. | Baseline, Day 30, Day 60, and Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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Triple (Participant, Investigator, Outcomes Assessor)
| Placebo | Dietary Supplement | Participants in this arm will take three placebo capsules daily after the final meal of the day for 90 days. The placebo capsules will contain an inert substance that mimics the appearance of the ProstaThrive™ supplement. |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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