Use of Lapis Judaicus to Dissolve Kidney Stones

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pouya Faridi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01443702
First received: September 25, 2011
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01443702

Locations
Iran, Islamic Republic of
Motahhari Medical Center
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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
ClinicalTrials.gov 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:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on April 17, 2014