Renal StonesNCT06681116
Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation
A study testing structured nano-water, Hydrochlorothiazide (HCTZ) and ordinary bottled drinking water in people with Renal Stones and Idiopathic Hypercalciuria, run by ALI KAMAL M. SAMI at 1 site in Iraq.
Trial summary
We assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Stones, Idiopathic Hypercalciuria
- What is being tested?
- structured nano-water, Hydrochlorothiazide (HCTZ) and ordinary bottled drinking water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 1 siteIraq
- Study dates
- 16 Feb 2015to 24 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic hypercalciuria
- history of previous renal stones
Who cannot join
- already present renal stones
- previous surgery of the kidneys
- Congenital anomalies of the urinary system
- Renal failure
- Allergy to hydrochlorothiazide
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Medicine, University of Suliamani
Sulaymaniyah, Kurdistan Region, 46001
About this study
We assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria.
Read the detailed description
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 .
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
- Renal Stones, Idiopathic Hypercalciuria
- Being tested
- structured nano-water, Hydrochlorothiazide (HCTZ), ordinary bottled drinking water
- Keywords
- recurrent renal stones, idiopathic hypercalciuria, nano-water, hydrochlorthiazide
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured nano-waterDietary supplement
Hydrochlorothiazide is a drug used to prevent recurrent renal stone formation in patients with idiopathic hypercalciuria
Hydrochlorothiazide (HCTZ)Drug
hydrochlorothiazide is a drug used to prevent recurrent stone formation i patients with idiopathic hypercalciuria
ordinary bottled drinking waterOther
Patients with idiopathic hypercalciuria receiving regular bottled drinking water as a placebo to see its effect.
| Study group | Role | What they receive |
|---|---|---|
| Patients with idiopathic hypercalciuria Group A | Experimental | Patients receiving nano-water in a daily dose of 20 mL/Kg Receives: Dietary Supplement: structured nano-water |
| Patients with idiopathic hypercalciuria Group B | Active comparator | Patients receiving Hydrochlorothiazide in a daily dose of 50 mg. Receives: Drug: Hydrochlorothiazide (HCTZ) |
| Patients with idiopathic hypercalciuria Group C | Placebo comparator | Patients receiving ordinary bottled drinking water in a daily dose of 20 mL/Kg Receives: Other: ordinary bottled drinking water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent renal stones
recurrent renal stone were diagnosed by ultrasound and X-ray ( kidney ureter Bladder X-ray)
Measured: From enrollment to the end of treatment at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start16 Feb 2015
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups that run parallel and receive the different allocated modalities and are followed up for three consecutive years
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALI KAMAL M. SAMI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALI KAMAL M. SAMI, University of Sulaimani
- Investigators
- Ali K M. Sami, MBChB FIBMS, Principal investigator, College of Medicine, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681116
- Sponsor's protocol ID
- 173
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients agreed to participate in this clinical trial based on keeping confidentiality about their personal informations
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation
- ClinicalTrials.gov ID
- NCT06681116
- Acronym / sponsor ID
- 173
- Conditions
- Renal Stones, Idiopathic Hypercalciuria
- Keywords
- recurrent renal stones, idiopathic hypercalciuria, nano-water, hydrochlorthiazide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- ALI KAMAL M. SAMIUniversity, hospital or other
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria.
Detailed description
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 .
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups that run parallel and receive the different allocated modalities and are followed up for three consecutive years
| Arm | Type | Receives |
|---|---|---|
| Patients with idiopathic hypercalciuria Group A | Experimental | Dietary Supplement: structured nano-waterPatients receiving nano-water in a daily dose of 20 mL/Kg |
| Patients with idiopathic hypercalciuria Group B | Active comparator | Drug: Hydrochlorothiazide (HCTZ)Patients receiving Hydrochlorothiazide in a daily dose of 50 mg. |
| Patients with idiopathic hypercalciuria Group C | Placebo comparator | Other: ordinary bottled drinking waterPatients receiving ordinary bottled drinking water in a daily dose of 20 mL/Kg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic hypercalciuria
- history of previous renal stones
Key exclusion criteria (5 listed)
- already present renal stones
- previous surgery of the kidneys
- Congenital anomalies of the urinary system
- Renal failure
- Allergy to hydrochlorothiazide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured nano-waterHydrochlorothiazide is a drug used to prevent recurrent renal stone formation in patients with idiopathic hypercalciuria | Dietary supplement | Patients with idiopathic hypercalciuria Group A |
| Hydrochlorothiazide (HCTZ)hydrochlorothiazide is a drug used to prevent recurrent stone formation i patients with idiopathic hypercalciuria | Drug | Patients with idiopathic hypercalciuria Group B |
| ordinary bottled drinking waterPatients with idiopathic hypercalciuria receiving regular bottled drinking water as a placebo to see its effect. | Other | Patients with idiopathic hypercalciuria Group C |
Primary outcome
Recurrent renal stones
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. Patients agreed to participate in this clinical trial based on keeping confidentiality about their personal informations
Related trials for Renal Stones
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali K M. Sami, MBChB FIBMS principal investigator
College of Medicine, University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured nano-water, Hydrochlorothiazide (HCTZ) and ordinary bottled drinking water in people with Renal Stones and Idiopathic Hypercalciuria, run by ALI KAMAL M. SAMI at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent renal stones (time frame: From enrollment to the end of treatment at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.