ACTRN12623000861651尚未招募2 期
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.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
- •1. Pregnant or breast-feeding women
- •2. Unwilling to use effective contraception during the trial (those of child-bearing capacity only)
研究者
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