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Efficacy and Safety of L-O-M® MCS in the Treatment of Lower Urinary Tract Symptoms

2014-08-27 03:18:22 | BioPortfolio

Summary

The hypothesis of the study is to examine whether L-O-M® Multi-Carotenoids (MCS) is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Description

Eligible male subjects will be randomized at 2:1 ratio to receive either L-O-M MCS or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study. However, participating subjects will be advised to avoid consuming foods with extra sources of lycopene. A list of restricted foods will be supplied at the Screening visit.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Lower Urinary Tract Symptoms

Intervention

L-O-M MCS, Placebo

Location

Chang Gung Medical Foundation, Chiayi Branch
Chiayi
Taiwan
10002

Status

Active, not recruiting

Source

Health Ever Bio-Tech Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:22-0400

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Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

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