Use of Lapis Judaicus to Dissolve Kidney Stones | NCT01443702

Studies
Use of Lapis Judaicus to Dissolve Kidney Stones

NCT01443702

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Dec 2, 2013Estimated

Enrollment

60Actual

Phase

Phase 1Phase 2

Conditions

Kidney Calculi

Interventions

Lapis Judaicus
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Not provided

First Submitted Date

Sep 25, 2011

First Submission Date that Met QC Criteria

Sep 29, 2011

First Posted Date

Sep 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2013

Last Update Posted Date

Dec 2, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pouya Faridi, Principal Investigator, Shiraz University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Lapis judaicus	Active Comparator		Drug: Lapis Judaicus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lapis Judaicus	Drug	2 g capsule per day.	Lapis judaicus
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stone size after 12 weeks	24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT	8 weeks and 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jamshid Roozbeh, MD	Shiraz University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Motahhari Medical Center		Shiraz	Fars		Iran

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided