Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation
NCT ID: NCT06681116
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
325 participants
INTERVENTIONAL
2015-02-16
2020-08-24
Brief Summary
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Detailed Description
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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 .
The assessments were done by urine analysis with renal ultrasonography and radiology ( Kidney Ureter Bladder KUB X-rays) were done at baseline, at yearly intervals, also at any time of recurrence, and at the end of the 3 years (36th month).
The patients, care providers, and the investigators were blinded about the type of water used since the water bottles were unlabeled when given to the patients.
All patients were informed and signed a written informed consent form.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Patients with idiopathic hypercalciuria Group A
Patients receiving nano-water in a daily dose of 20 mL/Kg
structured nano-water
Hydrochlorothiazide is a drug used to prevent recurrent renal stone formation in patients with idiopathic hypercalciuria
Patients with idiopathic hypercalciuria Group B
Patients receiving Hydrochlorothiazide in a daily dose of 50 mg.
Hydrochlorothiazide (HCTZ)
hydrochlorothiazide is a drug used to prevent recurrent stone formation i patients with idiopathic hypercalciuria
Patients with idiopathic hypercalciuria Group C
Patients receiving ordinary bottled drinking water in a daily dose of 20 mL/Kg
ordinary bottled drinking water
Patients with idiopathic hypercalciuria receiving regular bottled drinking water as a placebo to see its effect.
Interventions
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structured nano-water
Hydrochlorothiazide is a drug used to prevent recurrent renal stone formation in patients with idiopathic hypercalciuria
Hydrochlorothiazide (HCTZ)
hydrochlorothiazide is a drug used to prevent recurrent stone formation i patients with idiopathic hypercalciuria
ordinary bottled drinking water
Patients with idiopathic hypercalciuria receiving regular bottled drinking water as a placebo to see its effect.
Eligibility Criteria
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Inclusion Criteria
* history of previous renal stones
Exclusion Criteria
* previous surgery of the kidneys
* Congenital anomalies of the urinary system
* Renal failure
* Allergy to hydrochlorothiazide
18 Years
80 Years
ALL
No
Sponsors
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ALI KAMAL M. SAMI
OTHER
Responsible Party
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ALI KAMAL M. SAMI
Lecturer, College of Medicine,
Principal Investigators
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Ali K M. Sami, MBChB FIBMS
Role: PRINCIPAL_INVESTIGATOR
College of Medicine, University of Sulaimani
Locations
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College of Medicine, University of Suliamani
Sulaymaniyah, Kurdistan Region, Iraq
Countries
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Other Identifiers
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173
Identifier Type: -
Identifier Source: org_study_id
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