A Clinical Trial to see if a herbal medicine, Urox can prevent the recurrence of a urinary tract infections (UTIs) and cystitis.
A phase IIb Double-Blind, Placebo-controlled Randomised Clinical Trial assessing the efficacy of Urox for the prevention of recurrent urinary tract infections (UTIs) and cystitis.
Southern Cross University
202 participants
Aug 3, 2023
Interventional
Conditions
Summary
Urinary tract infections (UTI) pose a significant health concern for women, with as many as 50% being affected, and a quarter developing chronic UTI or interstitial cystitis. There are several herbs with well-established antimicrobial properties, and natural products and supplements have shown promise in supporting overall urinary health, as well as providing protection and prevention against UTIs. This trial aims to examine the efficacy and safety of Urox® for preventing UTIs and cystitis in women experiencing recurrent urinary tract infections.
Eligibility
Inclusion Criteria1
- 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 Criteria25
- Medical History
- Symptoms of acute systemic inflammatory response, infection, or fever (sweats/chills) at screening
- History of physical urinary tract abnormalities
- History of an unmanaged and/or poorly managed chronic disease
- Recent (within previous 6 months) history of kidney stones (renal calculi)
- History of chronic kidney disease or kidney dysfunction
- History of chronic kidney infection (chronic pyelonephritis)
- History of bladder or kidney cancer or other significant urinary co-morbidity
- Presence of an indwelling or suprapubic catheter, or current use of in/out catheters to aid urination
- Known allergy to any of the ingredients in the IMP
- Medications
- Current administration of antibiotics
- 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.
- Concurrent administration of any supplement containing any ingredient of the IMP
- Current treatment for cancer except hormone deprivation therapy or hormone blocking medication
- Current use of anti-diabetic drugs e.g. metformin, insulin
- Current use of lithium
- Pathology abnormalities
- Liver enzymes if greater than 1.5 x ULN
- eGFR if below 70 on screening pathology
- Urine pathology indicative of current UTI/infective cystitis
- TSH > 5 (males only)
- Other
- Pregnant or breast-feeding women
- Unwilling to use effective contraception during the trial (those of child-bearing capacity only)
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Interventions
UROX® is a herbal therapeutic good, a proprietary combination of three herbal extracts, listed with the Australian Therapeutics Goods Administration, AUSTL400655. UROX contains Horsetail 150mg, Lindera 150mg and Crateva 120mg in one capsule. Dose: 2 capsules a day in the morning for 6 months Compliance: 4 weekly follow up (online) visits will be conducted to assess number of capsules left for each participant for the 6 months. Blood tests will be conducted at screening and at 6 months, urine tests will be conducted at each acute episode from a participant.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623000861651