Use of Lapis Judaicus to Dissolve Kidney Stones

Kidney Calculi Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443702
• Other study ID #: Shirazums CT-90-5677
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 25, 2011
• Last updated: November 29, 2013
• Start date: January 2011

Study information

• Verified date: November 2013
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi

Intervention

Drug:
• Lapis Judaicus
2 g capsule per day.
• Placebo
2 g capsule per day.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Motahhari Medical Center	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone size after 12 weeks	24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT	8 weeks and 12 weeks	Yes