Use of Lapis Judaicus to Dissolve Kidney Stones

This study has been completed.
Information provided by (Responsible Party):
Pouya Faridi, Shiraz University of Medical Sciences Identifier:
First received: September 25, 2011
Last updated: November 29, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Kidney Calculi
Drug: Lapis Judaicus
Drug: Placebo
Phase 1
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Stone size after 12 weeks [ Time Frame: 8 weeks and 12 weeks ] [ Designated as safety issue: Yes ]
    24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT

Enrollment: 60
Study Start Date: January 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
2 g capsule per day.
Active Comparator: Lapis judaicus Drug: Lapis Judaicus
2 g capsule per day.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01443702

Iran, Islamic Republic of
Motahhari Medical Center
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Study Chair: Jamshid Roozbeh, MD Shiraz University of Medical Sciences
  More Information

No publications provided

Responsible Party: Pouya Faridi, Principal Investigator, Shiraz University of Medical Sciences Identifier: NCT01443702     History of Changes
Other Study ID Numbers: Shirazums CT-90-5677
Study First Received: September 25, 2011
Last Updated: November 29, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Shiraz University of Medical Sciences:
Kidney Calculi
Iranian traditional medicine
Lapis judaicus

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi processed this record on April 17, 2014