Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
Study NCT ID:
NCT05945667
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Uronext® in Women With Cystitis
Sponsor:
PharmaLinea Ltd.
Organization:
Study Overview
Official Title:
Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women With Cystitis in the Acute Stage
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: