NCT01443702

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

September 25, 2011

Last Update Submit

November 29, 2013

Conditions

Kidney Calculi

Keywords

Kidney CalculiIranian traditional medicineLapis judaicus

Outcome Measures

Primary Outcomes (1)

  • Stone size after 12 weeks

    24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT

    8 weeks and 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Lapis judaicus

ACTIVE COMPARATOR
Drug: Lapis Judaicus

Interventions

Lapis JudaicusDRUG

2 g capsule per day.

Lapis judaicus
PlaceboDRUG

2 g capsule per day.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prisoner
  • Pregnant
  • CKD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motahhari Medical Center

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jamshid Roozbeh, MD

    Shiraz University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 30, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

IR(1)