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Efficacy and Safety of Uronext® in Women With Cystitis

NCT05945667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2023-07-27

No results posted yet for this study

Summary

The study is designed as a prospective parallel open label, two-arm, single center study exploring efficacy and safety of the use of the dietary supplement Uronext in women with cystitis in the acute stage. 120 otherwise healthy women with acute cystitis infection confirmed with the urine bacteriological examinations, aged 18-18 years, will be recruited. The distribution of patients will be done in 1:1 ratio. Control group will receive standard therapy, Monural (fosfomycin trometamol) 3 g, at the first day of the trial. The second group will also receive Monural (fosfomycin trometamol) 3 g, at the first day of the trial as well as Uronext food supplement, 1 time per day for the first 7 days. After the 7 day break, participants in the second group will follow supplementation scheme for the next 3 month.

Primary objective of the study is evaluation of the effectiveness of the dietary supplement Uronext in women with cystitis in the acute stage in the prevention of subsequent exacerbations of recurrent cystitis during 3 months of observation, measured as the number of relapses throughout the study period. Participnats will also fill in urination diary and questionnaires related to pain perception, quality of life and cystitis symptoms. Urine samples will be further examined at the follow up visits.

Safety will be evaluated based on reported adverse events, assessment of vital signs and laboratory evaluation.

Conditions

  • Cystitis

Interventions

DRUG

Monural

1 sachet, only 1st day of trial

DIETARY_SUPPLEMENT

UroNext

1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months

Sponsors & Collaborators

  • NPO Petrovax Pharm LLC.

    collaborator UNKNOWN

  • PharmaLinea Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2021-12-21
Completion
2022-02-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945667 on ClinicalTrials.gov