Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	Himalaya Herbal Healthcare
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00381849

Purpose

We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 58 week trial. The first phase of the study will be two 6 weeks periods during which each subject will receive Cystone or placebo in random order. The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by CT scanning.

Condition	Intervention
Cystinuria Calcium Nephrolithiasis	Drug: Cystone

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Cystone for Treatment of Nephrolithiasis

Resource links provided by NLM:

Genetics Home Reference related topics: cystinuria

MedlinePlus related topics: Calcium Kidney Stones

Drug Information available for: Cystone

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

24 hour urine chemistries
24 hour urine supersaturation
Stone quantification CT

Estimated Enrollment:	20
Study Start Date:	April 2006

Detailed Description:

Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Cystinurics must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urine supersaturations or cystine, pH and sodium determinations will be collected. Then all patients enter an open label phase of 48 weeks. Entry and final stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Age 21 or over
Mentally competent
Not a prisoner
Not pregnant
Medically effective birth control if fertile female
History of calcium containing stone OR cystine containing stone AND current quantifiable stone
Able to comply with protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381849

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Himalaya Herbal Healthcare

Investigators

Principal Investigator:

Stephen B. Erickson, M.D.

Mayo Clinic

More Information

No publications provided

Study ID Numbers:	2115-05
Study First Received:	September 27, 2006
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00381849 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Metabolism, Inborn Errors
Metabolic Diseases
Renal Aminoacidurias
Genetic Diseases, Inborn
Urologic Diseases

Cystinuria
Urolithiasis
Kidney Diseases
Renal Tubular Transport, Inborn Errors
Nephrolithiasis

ClinicalTrials.gov processed this record on November 05, 2009