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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06504472

Enrollment

Registered

2024-07-16

Start date

2024-02-07

Completion date

2024-06-24

Last updated

2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Erectile Dysfunction, Lower Urinary Tract Symptoms

Keywords

Pumpkin Seed Extract, Lycopene, Stinging Nettle, Beta-Sitosterols

Brief 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.

Interventions

DIETARY_SUPPLEMENTProstaThrive™ Supplement

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

DIETARY_SUPPLEMENTPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Triple (Participant, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Lower Urinary Tract Symptoms (LUTS)	Baseline, Day 30, Day 60, and Day 90	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).

Secondary

Measure	Time frame	Description
Change in Sexual Function and Performance	Baseline, Day 30, Day 60, and Day 90	Measured by the ability to get and maintain an erection at Baseline, Day 30, Day 60, and Day 90 via study-specific questionnaires.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026