CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
UClear +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06719115
NCT06719115Phase 2Completed

A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of D-Mannose on Symptoms of Urinary Tract Infection in Women

KEB Nutraceuticals USA, Inc.·interventional·Posted Dec 5, 2024·Updated Dec 5, 2024

In Brief

A Phase 2 clinical trial evaluating UClear and Placebo for Urinary Tract Infection(UTI). Completed, enrolled 30 participants across 1 site.

Detailed Summary

The objective of this acute study was to investigate the safety and efficacy of UClear for the resolution of urinary tract infection (UTI) symptoms in women. The main questions it aims to answer is: 1. Is there a difference in proportion of participants with complete resolution of UTI symptoms at Day 4 between UClear and placebo 2. Is there a difference in change from baseline (Day 1) at Day 4 between UClear and placebo in Urinary Tract Infection Symptom Assessment (UTISA) symptom severity scores. Participants will take UClear or placebo twice a day for 3 days with or without food, have 4 in clinical visits, and will be instructed to complete a quality of life (QoL) questionnaire during each visit and a UTISA questionnaire at follow-up (Day 7).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsKGK Science Inc.

Timeline

Phase 2CompletedFinished
202420252026
First PostedDec 5, 2024
Enrollment StartMay 3, 2023
Primary CompletionJun 20, 2024
TodayJul 1, 2026
Enrollment to primary: 1.1 yearsPosted 1.6 years ago

Interventions

UCleardietary

Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).

Placeboother

Take one dose twice a day for three days with or without food, starting on Day 1 (baseline visit).