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

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

Genetics Home Reference related topics:

cystinuria

MedlinePlus related topics:

Kidney Stones

ChemIDplus related topics:

Cystone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	Cystone for Treatment of Nephrolithiasis

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	Recruiting
	Rochester, Minnesota, United States, 55905
	Contact: Ellen R. Olson 507-255-3984 olson.ellen@mayo.edu
	Principal Investigator: Stephen B. Erickson, M.D.

Sponsors and Collaborators

Mayo Clinic

Himalaya Herbal Healthcare

Investigators


Principal Investigator:	Stephen B. Erickson, M.D.	Mayo Clinic

More Information

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