Cystone for Treatment of Nephrolithiasis

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

Sponsors

Lead sponsor: Mayo Clinic

Collaborator: Himalaya Herbal Healthcare
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source Mayo Clinic
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.

Overall Status Completed
Start Date April 2006
Completion Date June 2010
Primary Completion Date September 2009
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx) baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite) baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite) baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
24 Hour Urinary Cystine Excretion baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
Stone Density as Measured by Agatston Score Via Computerized Tomography Baseline, approximately 52 weeks after baseline
Volume of Kidney Stones as Measured on Computerized Tomography Baseline, approximately 52 weeks after baseline
Secondary Outcome
Measure Time Frame
Change in Stone Burden as Assessed by Radiologist at One Year Baseline, approximately 52 weeks after baseline
Enrollment 20
Condition
Intervention

Intervention type: Drug

Intervention name: Cystone

Description: Participants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.

Other name: Uricare

Intervention type: Drug

Intervention name: Sugar Pill (Placebo)

Description: Participants will take 2 pills, 2 times a day for 6 weeks.

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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Stephen B. Erickson, M.D. Principal Investigator Mayo Clinic
Location
facility
Mayo Clinic
Location Countries

United States

Verification Date

January 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mayo Clinic

Investigator full name: Stephen B. Erickson, M.D.

Investigator title: PI

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Cystone then sugar pill

Arm group type: Active Comparator

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

Arm group label: Sugar pill then Cystone

Arm group type: Placebo Comparator

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

Arm group label: Open-label Cystone

Arm group type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov