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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-06-24

Brief Summary

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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.

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Detailed Description

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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

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Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple (Participant, Investigator, Outcomes Assessor)

Study Groups

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Intervention (ProstaThrive™)

Participants will take three capsules daily after the final meal of the day for 90 days.

Group Type EXPERIMENTAL

ProstaThrive™ Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Participants will take three placebo capsules daily after the final meal of the day for 90 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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ProstaThrive™ Supplement

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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No