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Use of Lapis Judaicus to Dissolve Kidney Stones

Phase 1
Completed
Conditions
Kidney Calculi
Interventions
Drug: Placebo
Drug: Lapis Judaicus
Registration Number
NCT01443702
Lead Sponsor
Shiraz University of Medical Sciences
Brief 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. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • 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
Exclusion Criteria
  • Prisoner
  • Pregnant
  • CKD

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
Lapis judaicusLapis Judaicus-
Primary Outcome Measures
NameTimeMethod
Stone size after 12 weeks8 weeks and 12 weeks

24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Motahhari Medical Center

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Shiraz, Fars, Iran, Islamic Republic of

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