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

Optimale80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Erectile Dysfunction

Interventions

ProstaThrive™ SupplementDIETARY_SUPPLEMENT

Participants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days.

PlaceboDIETARY_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.

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male participants aged 40+ * Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination * Difficulty in getting or maintaining an erection * Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period Exclusion Criteria: * Recent surgeries or invasive treatments * History of prostate or male reproductive cancers * Urinary issues caused by neurological conditions * Previous surgery on the genitals, prostate, bladder, or urethra * Known allergies to product ingredients * Diagnosed with chronic health conditions impacting study participation * Current substance abuse * Participation in other clinical trials * Taking medications or supplements targeting LUTS or erectile dysfunction

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Day 30, Day 60, and Day 90

Secondary Outcomes

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.

Time frame: Baseline, Day 30, Day 60, and Day 90

Data from ClinicalTrials.gov

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