A Clinical Trial to see if a herbal medicine, Urox can prevent the recurrence of a urinary tract infections (UTIs) and cystitis.

Phase 2

• Conditions: Recurrent Urinary tract infections; Recurrent Cystitis; Renal and Urogenital - Other renal and urogenital disorders; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12623000861651
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-11
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

History of recurrent UTI or cystitis (self-reported previous medical diagnosis) defined as at least two episodes of UTI and/or acute cystitis in the last 6 months and/or at least 3 episodes of UTI and/or acute cystitis in the last 12 months

Exclusion Criteria

Those who fulfil the following exclusion criteria cannot be considered for participation:

Medical History
1. Symptoms of acute systemic inflammatory response, infection, or fever (sweats/chills) at screening
2. History of physical urinary tract abnormalities
3. History of an unmanaged and/or poorly managed chronic disease
4. Recent (within previous 6 months) history of kidney stones (renal calculi)
5. History of chronic kidney disease or kidney dysfunction
6. History of chronic kidney infection (chronic pyelonephritis)
7. History of bladder or kidney cancer or other significant urinary co-morbidity
8. Presence of an indwelling or suprapubic catheter, or current use of in/out catheters to aid urination
9. Known allergy to any of the ingredients in the IMP

Medications
1. Current administration of antibiotics
2. Current administration of natural prophylaxis such as cranberry or d-mannose or other natural supplements or herbal medicine for urinary tract infections/cystitis treatment or associated symptoms. These supplements may be ceased for 28 days to allow for trial inclusion at the participant’s discretion.
3. Concurrent administration of any supplement containing any ingredient of the IMP
4. Current treatment for cancer except hormone deprivation therapy or hormone blocking medication
5. Current use of anti-diabetic drugs e.g. metformin, insulin
6. Current use of lithium

Pathology abnormalities
1. Liver enzymes if greater than 1.5 x ULN
2. eGFR if below 70 on screening pathology
3. Urine pathology indicative of current UTI/infective cystitis
4. TSH > 5 (males only)

Other
1. Pregnant or breast-feeding women
2. Unwilling to use effective contraception during the trial (those of child-bearing capacity only)

Study & Design

• Study Type: Interventional
• Study Design: Not specified