Kidney CalculiPhase 1/2NCT01443702
Use of Lapis Judaicus to Dissolve Kidney Stones
A Phase 1/2 study testing Lapis Judaicus in people with Kidney Calculi, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Lapis Judaicus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 1/2
- 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
- Age 18 or over
- Mentally competent
- Medically effective birth control if fertile female
- History of calcium containing stone AND current quantifiable stone
- Able to comply with protocol
Who cannot join
- Prisoner
- Pregnant
- CKD
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. End points are changes in urinary chemistries and stone burden by Ultra sonography / CT scan.
It will be used in proven calcium stone forming adults who are not pregnant. This phase is a double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine supersaturations, pH and sodium determinations will be collected. Entry and final stone quantification Ultra sonography / CT scan will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.
- Conditions
- Kidney Calculi
- Being tested
- Lapis Judaicus, Placebo
- Keywords
- Kidney Calculi, Iranian traditional medicine, Lapis judaicus
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapis JudaicusDrug
2 g capsule per day.
PlaceboDrug
2 g capsule per day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Lapis judaicus | Active comparator | Not described Receives: Drug: Lapis Judaicus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone size after 12 weeks
24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT
Measured: 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouya Faridi, Shiraz University of Medical Sciences
- Investigators
- Jamshid Roozbeh, MD, Study chair, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443702
- Sponsor's protocol ID
- Shirazums CT-90-5677
- Status last verified
- Nov 2013
- First submitted
- 25 Sep 2011
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lapis Judaicus to Dissolve Kidney Stones
- ClinicalTrials.gov ID
- NCT01443702
- Acronym / sponsor ID
- Shirazums CT-90-5677
- Conditions
- Kidney Calculi
- Keywords
- Kidney Calculi, Iranian traditional medicine, Lapis judaicus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2011 (estimated)
- 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.
The investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. End points are changes in urinary chemistries and stone burden by Ultra sonography / CT scan.
It will be used in proven calcium stone forming adults who are not pregnant. This phase is a double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine supersaturations, pH and sodium determinations will be collected. Entry and final stone quantification Ultra sonography / CT scan will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Lapis judaicus | Active comparator | Drug: Lapis Judaicus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or over
- Mentally competent
- Medically effective birth control if fertile female
- History of calcium containing stone AND current quantifiable stone
- Able to comply with protocol
Key exclusion criteria (3 listed)
- Prisoner
- Pregnant
- CKD
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 |
|---|---|---|
| Lapis Judaicus2 g capsule per day. | Drug | Lapis judaicus |
| Placebo2 g capsule per day. | Drug | Placebo |
Primary outcome
Stone size after 12 weeks
Time frame: 8 weeks and 12 weeks
24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT
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 2 Dec 2013.
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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.
Jamshid Roozbeh, MD study chair
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lapis Judaicus in people with Kidney Calculi, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 3 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 2 Dec 2013. 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 Iran. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stone size after 12 weeks (time frame: 8 weeks and 12 weeks). 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 2 Dec 2013.