NCT06504472

A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Optimale · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lower Urinary Tract Symptoms
• Benign Prostatic Hyperplasia
• Erectile Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ProstaThrive™ Supplement	Participants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days.
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2024-02-07
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: United States