Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

This study has been completed.
Sponsor:
Collaborators:
Himalaya Herbal Healthcare
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00381849
First received: September 27, 2006
Last updated: June 12, 2012
Last verified: June 2012

September 27, 2006
June 12, 2012
April 2006
September 2009   (final data collection date for primary outcome measure)
  • 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx) [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ] [ Designated as safety issue: No ]
    Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
  • 24 Hour Urine Supersaturation of Calcium Phosphate (Brushite) [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ] [ Designated as safety issue: No ]
    Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
  • 24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite) [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ] [ Designated as safety issue: No ]
    Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
  • 24 Hour Urinary Cystine Excretion [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ] [ Designated as safety issue: No ]
  • Stone Density as Measured by Agatston Score Via Computerized Tomography [ Time Frame: Baseline, approximately 52 weeks after baseline ] [ Designated as safety issue: No ]
    Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
  • Volume of Kidney Stones as Measured on Computerized Tomography [ Time Frame: Baseline, approximately 52 weeks after baseline ] [ Designated as safety issue: No ]
    Measurement of kidney stone volume in cubic millimeters.
  • 24 hour urine chemistries
  • 24 hour urine supersaturation
  • Stone quantification CT
Complete list of historical versions of study NCT00381849 on ClinicalTrials.gov Archive Site
Change in Stone Burden as Assessed by Radiologist at One Year [ Time Frame: Baseline, approximately 52 weeks after baseline ] [ Designated as safety issue: No ]
Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.
Not Provided
Not Provided
Not Provided
 
Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
Cystone for Treatment of Nephrolithiasis

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cystinuria
  • Nephrolithiasis, Calcium Oxalate
  • Drug: Cystone

    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
  • Drug: Sugar Pill (Placebo)
    Participants will take 2 pills, 2 times a day for 6 weeks.
  • Active Comparator: Cystone then sugar pill
    Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks
    Interventions:
    • Drug: Cystone
    • Drug: Sugar Pill (Placebo)
  • Placebo Comparator: Sugar pill then Cystone
    Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks
    Interventions:
    • Drug: Cystone
    • Drug: Sugar Pill (Placebo)
  • Experimental: Open-label Cystone
    All subjects will receive Cystone for 46 weeks in the open-label period.
    Intervention: Drug: Cystone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00381849
2115-05, P50DK083007
No
Stephen Erickson, MD, Mayo Clinic
Mayo Clinic
  • Himalaya Herbal Healthcare
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Stephen B. Erickson, M.D. Mayo Clinic
Mayo Clinic
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP