ISRCTN43397016已完成3 期
Alternative Treatments of Adult Female Urinary Tract Infection: a double-blind, placebo-controlled, factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen
niversity of Southampton0 个研究点目标入组 376 人开始时间: 2015年2月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 376
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28886751 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30685500
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Adult women (18-70) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency
- •2. Patient able to provide informed written consent
- •3. Women willing to accept a delayed prescription for antibiotics
排除标准
- •Current exclusion criteria as of 13/09/2016:
- •1. Known or suspected pregnancy or breast feeding. In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
- •2. Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
- •3. Diabetes
- •4. Has any of the following known contraindications or cautions to Ibuprofen and any as listed in the current SmPC:
- •4.1. Asthmatics sensitive to NSAIDS/Ibuprofen or Aspirin
- •4.2. Severe heart failure and uncontrolled hypertension
- •4.3. Active gastrointestinal ulceration or bleeding
- •4.4. Crohn’s disease or ulcerative colitis
- •4.5. Documented poor renal function
- •4.6. Chronic Kidney disease (Grade 3-5)
- •5. Currently or within 7 days taken antibiotics
- •6. Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
- •7. Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
- •8. Women whom immediate antibiotics are otherwise indicated frequent recurrent infection: >3 UTI episodes in past 12 months
- •9. Defect of the blood clotting system
- •10. Bladder surgery including cystoscopy in the last four weeks
- •11. Currently taking Warfarin
- •12. Recruited to another interventional trial in previous 6 weeks
- •Previous exclusion criteria:
- •1. Known or suspected pregnancy or breast feeding. In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
- •2. Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
- •3. Diabetes
- •4. Has any of the following known contraindications or cautions to Ibuprofen and any as listed in the current SmPC:
- •4.1. Asthmatics sensitive to NSAIDS/Ibuprofen or Aspirin
- •4.2. Severe heart failure and uncontrolled hypertension
- •4.3. Active gastrointestinal ulceration or bleeding
- •4.4. Crohn’s disease or ulcerative colitis
- •4.5. Documented poor renal function
- •4.6. Chronic Kidney disease
- •5. Currently or within 7 days taken antibiotics
- •6. Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
- •7. Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
- •8. Women whom immediate antibiotics are otherwise indicated frequent recurrent infection: >3 UTI episodes in past 12 months
- •9. Defect of the blood clotting system
- •10. Bladder surgery including cystoscopy in the last four weeks.
- •11. Currently taking Warfarin
- •12. Recruited to another trial in previous 4 weeks.
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