Clinical Trial of Nettle and Cranberry Capsules for Prevention of Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- UTI-free duration in 8 weeks
研究概览
简要总结
This study investigates whether the oral intake of a nettle and cranberry complex capsule may prevent recurrent urinary tract infection (rUTI). Participants will be aged between 30 - 75 years of age, with confirmed diagnosis of UTI status. The participants will be assessed for several parameters and asked to take 2 nettle and cranberry complex capsules twice daily for 8 weeks. The parameters will include international prostate symptoms score (IPSS), overactive bladder symptom score (OABSS), international consultation on incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary (3dBD), and urine routine.
详细描述
Urinary tract infections (UTIs) are one of the most common bacterial infections affecting women. UTI occurs in 50-80% of women in the general population. About one in four women with one UTI episode will go on to develop frequent recurrences.
Recurrent urinary tract infection (rUTI) is defined as repeated UTI with a frequency of at least two episodes in the preceding six months or three episodes in the past year. rUTI has been regarded as a substantial global healthcare problem.
This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of rUTI are randomly assigned to control group or treatment group, and asked to orally intake 2 capsules of either placebo or nettle and cranberry complex capsules twice daily. Participants will be assessed for parameters, including international prostate symptoms score (IPSS) (male only), overactive bladder symptom score (OABSS), international consultation on incontinence questionnaire - overactive bladder (ICIQ-OAB), 3-day bladder diary (3dBD) and urine routine. The assessments are conducted at baseline, 4 weeks, and 8 weeks after the oral intake period. The parameters are used to compare and evaluate whether the nettle and cranberry complex capsule can prevention rUTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 30 and 75 years
- •at least two episodes in 6 months, or at least three episodes of a UTI in 12 months.
排除标准
- •pregnancy women
- •History of anatomical urogenital anomalies, urogenital tract surgery
- •History of acute or chronic renal failure, nephrolithiasis
- •History of intestinal diseases causing malabsorption
- •Anticoagulant medication in the last month
- •immunocompromise
- •Known allergy or intolerance to cranberry
结局指标
主要结局
UTI-free duration in 8 weeks
时间窗: on baseline and 8 weeks
Comparing the number of days from the beginning of the study to the first recurrence of UTI, and the number of days from each recurrence to the next recurrence between different treatment groups.
UTI recurrent incidence in 8 weeks
时间窗: 8 weeks
UTI episodes during 8 weeks treatment for each subject
次要结局
- International Prostate Symptom Score (IPSS) Change from Baseline(on baseline,4 weeks and 8 weeks)
- Overactive Bladder Symptom Score (OABSS) Change from Baseline(on baseline,4 weeks and 8 weeks)
- Bladder diary(on baseline,4 weeks, and 8 weeks)
- International Consultation on Incontinence Questionnaire Overactive Bladder Score (ICIQ-OAB) Change from Baseline(on baseline,4 weeks, and 8 weeks)