Clinical trial NCT00381849: Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
Official title: Cystone for Treatment of Nephrolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cystinuria
Nephrolithiasis, Calcium Oxalate
Keywords: Cystone
Uricare
Computerized tomography
Kidney calculi
Supersaturation
Nephrolithiasis
Quantitative CT
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Himalaya Herbal Healthcare
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
timeFrame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
measure: 24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
timeFrame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
measure: 24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
timeFrame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
measure: 24 Hour Urinary Cystine Excretion
timeFrame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
measure: Stone Density as Measured by Agatston Score Via Computerized Tomography
timeFrame: Baseline, approximately 52 weeks after baseline
measure: Volume of Kidney Stones as Measured on Computerized Tomography
timeFrame: Baseline, approximately 52 weeks after baseline
Secondary outcomes:
measure: Change in Stone Burden as Assessed by Radiologist at One Year
timeFrame: Baseline, approximately 52 weeks after baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen B. Erickson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdollahiasl A, Kebriaeezadeh A, Nikfar S, Farshchi A, Ghiasi G, Abdollahi M. Patterns of antibiotic consumption in Iran during 2000-2009. Int J Antimicrob Agents. 2011 May;37(5):489-90. doi: 10.1016/j.ijantimicag.2011.01.022. Epub 2011 Mar 17. No abstract available.
citation: Erickson SB, Vrtiska TJ, Canzanello VJ, Lieske JC. Cystone(R) for 1 year did not change urine chemistry or decrease stone burden in cystine stone formers. Urol Res. 2011 Jun;39(3):197-203. doi: 10.1007/s00240-010-0334-x. Epub 2010 Dec 16.