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| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2006 |
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 |
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Stephen B. Erickson, M.D. | Mayo Clinic |
More Information
| 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 |
|
Metabolism, Inborn Errors Metabolic Diseases Renal Aminoacidurias Genetic Diseases, Inborn Urologic Diseases |
Cystinuria Urolithiasis Kidney Diseases Renal Tubular Transport, Inborn Errors Nephrolithiasis |