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临床试验/NCT04306731
NCT04306731已完成不适用

A Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Use of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

University of Sulaimani1 个研究点 分布在 1 个国家目标入组 437 人开始时间: 2014年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
437
试验地点
1
主要终点
Recurrent Urinary Tract Infection

研究概览

简要总结

This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females.

详细描述

This study represents the first time to use nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females. Urinary tract infection (UTI ) is the second most common bacterial infection, affecting women at a much higher frequency than men. There is a higher rate of recurrence of UTI, and a recurrent infection will follow 25-35% of initial UTI episodes within 3-6 months.

Intermittent or prolonged low dose antibiotic therapy has been used to treat and prevent recurrent UTI. Emerging of resistance to antimicrobial agents, enormous economic burden, and the side effects of antibiotics have led to the search for an alternative non-antibiotic prophylaxis of recurrent UTI. Nanotechnology structured water is a new type of drinking water that has been prepared using different types of energy fields and electromagnetic fields to produce this structured water, which has new and different characteristics from the ordinary water.

In the current study, the efficacy of nanotechnology structured water magnalife was compared with low-dose Trimethoprim and bottled drinking water for the prevention of recurrent UTI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
24 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ 2 (two or more than two) UTI in the last 6 months
  • ≥ 3 (three or more than three) UTI in the last 12 months

排除标准

  • immunotherapy
  • radiotherapy
  • malignancy
  • chronic infections
  • chemotherapy
  • immunosuppressive drugs
  • anatomical abnormality of the urinary tract
  • surgical operation the urinary tract

研究组 & 干预措施

Interventional (Group M)

Experimental

The group of patients given nanotechnology structured water magnalife

干预措施: Nanotechnology Structured water Magnalife (Dietary Supplement)

Control (Group T)

Active Comparator

The group of patients given Trimethoprim

干预措施: Trimethoprim (Drug)

Placebo (Group O)

Placebo Comparator

The group of patients given ordinary bottled drinking water

干预措施: Ordinary bottled drinking water (Dietary Supplement)

结局指标

主要结局

Recurrent Urinary Tract Infection

时间窗: Twelve months

Urinalysis by GUE (\>10 white blood cells (WBC)/mm3 per high-power field (HPF) Urine culture (urinary pathogen of ≥105 colony-forming units (CFU) per mL)

次要结局

  • Time to first recurrent UTI(Twelve months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ALI KAMAL M. SAMI

Principal investigator

University of Sulaimani

研究点 (1)

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