Kidney Calculi
Conditions
Keywords
Kidney Calculi, Iranian traditional medicine, Lapis judaicus
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.
Interventions
DRUGLapis Judaicus
2 g capsule per day.
DRUGPlacebo
2 g capsule per day.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone size after 12 weeks | 8 weeks and 12 weeks | 24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT |
Countries
Iran
Outcome results
None listed