Use of Lapis Judaicus to Dissolve Kidney Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443702
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : December 2, 2013
Information provided by (Responsible Party):
Pouya Faridi, 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.

Condition or disease Intervention/treatment Phase
Kidney Calculi Drug: Lapis Judaicus Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
2 g capsule per day.

Active Comparator: Lapis judaicus Drug: Lapis Judaicus
2 g capsule per day.

Primary Outcome Measures :
  1. Stone size after 12 weeks [ Time Frame: 8 weeks and 12 weeks ]
    24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Pouya Faridi, Principal Investigator, Shiraz University of Medical Sciences Identifier: NCT01443702     History of Changes
Other Study ID Numbers: Shirazums CT-90-5677
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

Keywords provided by Pouya Faridi, 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