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临床试验/NCT06681116
NCT06681116已完成不适用

Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation

ALI KAMAL M. SAMI1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2015年2月16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
发起方
入组人数
325
试验地点
1
主要终点
Recurrent renal stones

研究概览

简要总结

We assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria.

详细描述

The majority of stones (85%) contain primarily calcium oxalate. Most renal stones are idiopathic calcium stones, and the most common predisposing factor in these patients is hypercalciuria. Structured nano-water is a new type of water that has been prepared using different types of energy fields electromagnetic fields to produce this structured nano- water that has new and different characteristics from the ordinary water.

In this study, we compared the efficacy of the nano- water with hydrochlorothiazide and with ordinary bottled drinking water in the prevention of recurrent renal stones in patients with idiopathic hypercalciuria.

We conducted a three-year randomized trial comparing the effect of structured water with the effect of hydrochlorothiazide and ordinary bottled water in 325 patients with recurrent calcium oxalate stones and hypercalciuria.

The patients were randomly divided into three groups. Group A included 108 patients who used structured nano-water in a dose of 20 mL/kg as a daily dose.

Group B of 107 patients used 50 mg hydrochlorothiazide tablets as a daily dose, and group C consisted of another 110 patients used ordinary drinking bottled water in a daily dose of 20 mL/kg .

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)

盲法说明

neither the participants nor the investigators or the care givers and the outcome assessors knew the group of patients

入排标准

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

入选标准

  • Idiopathic hypercalciuria
  • history of previous renal stones

排除标准

  • already present renal stones
  • previous surgery of the kidneys
  • Congenital anomalies of the urinary system
  • Renal failure
  • Allergy to hydrochlorothiazide

研究组 & 干预措施

Patients with idiopathic hypercalciuria Group A

Experimental

Patients receiving nano-water in a daily dose of 20 mL/Kg

干预措施: structured nano-water (Dietary Supplement)

Patients with idiopathic hypercalciuria Group B

Active Comparator

Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.

干预措施: Hydrochlorothiazide (HCTZ) (Drug)

Patients with idiopathic hypercalciuria Group C

Placebo Comparator

Patients receiving ordinary bottled drinking water in a daily dose of 20 mL/Kg

干预措施: ordinary bottled drinking water (Other)

结局指标

主要结局

Recurrent renal stones

时间窗: From enrollment to the end of treatment at 36 months

recurrent renal stone were diagnosed by ultrasound and X-ray ( kidney ureter Bladder X-ray)

次要结局

未报告次要终点

研究者

发起方
ALI KAMAL M. SAMI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ALI KAMAL M. SAMI

Lecturer, College of Medicine,

University of Sulaimani

研究点 (1)

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