Use of an Herbal Preparation to Prevent & Dissolve Kidney Stones

Status Completed

Clinical Trial 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 59 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 (with a one-week wash out between 6 week treatment periods). The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by Computerized Tomography (CT) scanning.

Clinical Trial Description

Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects 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 46 weeks, ensuring a 52-week total exposure to Cystone during the 59 week study. Baseline and 1 year stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone burden. Stone burden was measured by CT, quantitatively for stone density and volume. All CT images were also reviewed in a blinded fashion by a radiologist to score each kidney as increased, no change or decreased stone burden.

Statistics and Randomization: Randomization was accomplished using a table provided by the department of statistics to the study coordinator who was blinded as to whether the patients received placebo or Cystone®. Biochemical and supersaturation results were analyzed via a matched pair analysis using the JMP software package (SAS Instituted, Inc.); P values < 0.05 were deemed significant. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00381849
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2006
Completion date	June 2010

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See also
Status	Clinical Trial	Phase
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Completed	`NCT02538016` - TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study	N/A
Recruiting	`NCT06065852` - National Registry of Rare Kidney Diseases
Recruiting	`NCT00169806` - Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis	N/A
Completed	`NCT03663855` - Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria	Phase 2
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Recruiting	`NCT02026388` - Rare Kidney Stone Consortium Biobank
Recruiting	`NCT04818034` - The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study	Phase 2
Withdrawn	`NCT04137978` - Study Evaluating Patients With Cystinuria	Phase 2/Phase 3
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Completed	`NCT05048563` - Registry of Thiola EC Therapy
Not yet recruiting	`NCT04147871` - Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children	Phase 2/Phase 3
Completed	`NCT02125721` - Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria	Phase 4
Active, not recruiting	`NCT02910531` - Lipoic Acid Supplement for Cystine Stone	Phase 2
Recruiting	`NCT00588562` - Rare Kidney Stone Consortium Patient Registry
Completed	`NCT02124395` - Health-related Quality of Life in Rare Kidney Stone
Not yet recruiting	`NCT05058859` - Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics	Phase 2
Active, not recruiting	`NCT03539926` - This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).	N/A
Completed	`NCT03836144` - Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms