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

Tracking Information

First Received Date ^ICMJE

September 27, 2006

Last Updated Date

January 5, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

24 hour urine chemistries
24 hour urine supersaturation
Stone quantification CT

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00381849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

Official Title ^ICMJE

Cystone for Treatment of Nephrolithiasis

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cystinuria
Calcium Nephrolithiasis

Intervention ^ICMJE

Drug: Cystone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00381849

Responsible Party

Study ID Numbers ^ICMJE

2115-05

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Himalaya Herbal Healthcare

Investigators ^ICMJE

Principal Investigator:

Stephen B. Erickson, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP