Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
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.
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 Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Cystinuria
Intervention
Cystone
Location
Mayo Clinic
Rochester
Minnesota
United States
55905
Status
Active, not recruiting
Source
Mayo Clinic
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00381849
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cystinuria
An inherited disorder due to defective reabsorption of CYSTINE and other BASIC AMINO ACIDS by the PROXIMAL RENAL TUBULES. This form of aminoaciduria is characterized by the abnormally high urinary levels of cystine; LYSINE; ARGININE; and ORNITHINE. Mutations involve the amino acid transport protein gene SLC3A1.
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