Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

Mayo Clinic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nephrolithiasis, Calcium Oxalate; Cystinuria

Treatments: Drug: Cystone; Drug: Sugar Pill (Placebo)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00381849

P50DK083007 (U.S. NIH Grant/Contract)

2115-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent In the cystine arm, all patients will have the diagnosis of cystinuria, made on the basis of a 24-hour urine cystine containing more than 1500 umol of cystine, or a stone compositional analysis of cystine
• Presence of an existing cystine stone in one or both kidneys In the calcium arm, all patients will have a history of a calcium stone as determined by laboratory analysis.
• Medically effective birth control if fertile female
• Able to comply with protocol

Exclusion criteria

• Pregnant
• Subjects under age 18 years
• Obstructing stones
• Urinary Tract Infection that cannot be cleared with single course of antibiotic
• Subjects who decline to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Cystone then sugar pill

Active Comparator group

Description:

Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks

Treatment:

Drug: Sugar Pill (Placebo)

Drug: Cystone

Sugar pill then Cystone

Placebo Comparator group

Description:

Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks

Treatment:

Drug: Sugar Pill (Placebo)

Drug: Cystone

Open-label Cystone

Experimental group

Description:

All subjects will receive Cystone for 46 weeks in the open-label period.

Treatment:

Drug: Cystone