Use of Lapis Judaicus to Dissolve Kidney Stones

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Calculi

Treatments: Drug: Placebo; Drug: Lapis Judaicus

Study type: Interventional

Funder types: Other

Identifiers

NCT01443702

Shirazums CT-90-5677

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Lapis judaicus

Active Comparator group

Treatment:

Drug: Lapis Judaicus