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Use of Lapis Judaicus to Dissolve Kidney Stones

Primary Purpose

Kidney Calculi

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lapis Judaicus
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring Kidney Calculi, Iranian traditional medicine, Lapis judaicus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Motahhari Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Lapis judaicus

Arm Description

Outcomes

Primary Outcome Measures

Stone size after 12 weeks
24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT

Secondary Outcome Measures

Full Information

First Posted
September 25, 2011
Last Updated
November 29, 2013
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01443702
Brief Title
Use of Lapis Judaicus to Dissolve Kidney Stones
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
Kidney Calculi, Iranian traditional medicine, Lapis judaicus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Lapis judaicus
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lapis Judaicus
Intervention Description
2 g capsule per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 g capsule per day.
Primary Outcome Measure Information:
Title
Stone size after 12 weeks
Description
24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT
Time Frame
8 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Motahhari Medical Center
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Use of Lapis Judaicus to Dissolve Kidney Stones

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