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

Optimale

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Erectile Dysfunction; Benign Prostatic Hyperplasia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: ProstaThrive™ Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06504472

20405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Intervention (ProstaThrive™)

Experimental group

Description:

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

Treatment:

Dietary Supplement: ProstaThrive™ Supplement

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo