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Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381849
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : August 6, 2012
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Himalaya Herbal Healthcare
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stephen B. Erickson, M.D., Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystinuria Nephrolithiasis, Calcium Oxalate Drug: Cystone Drug: Sugar Pill (Placebo) Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cystone for Treatment of Nephrolithiasis
Study Start Date : April 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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Arm Intervention/treatment
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
 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.
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
 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.
Experimental: Open-label Cystone
All subjects will receive Cystone for 46 weeks in the open-label period.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
  5. Stone Density as Measured by Agatston Score Via Computerized Tomography [ Time Frame: Baseline, approximately 52 weeks after baseline ]
    Agatston results are a measure of calcium typically used for measuring coronary artery calcification.

  6. Volume of Kidney Stones as Measured on Computerized Tomography [ Time Frame: Baseline, approximately 52 weeks after baseline ]
    Measurement of kidney stone volume in cubic millimeters.


Secondary Outcome Measures :
  1. Change in Stone Burden as Assessed by Radiologist at One Year [ Time Frame: Baseline, approximately 52 weeks after baseline ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381849


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Himalaya Herbal Healthcare
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Stephen B. Erickson, M.D. Mayo Clinic
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Stephen B. Erickson, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00381849    
Other Study ID Numbers: 2115-05
P50DK083007 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2006    Key Record Dates
Results First Posted: August 6, 2012
Last Update Posted: February 4, 2016
Last Verified: January 2016
Keywords provided by Stephen B. Erickson, M.D., Mayo Clinic:
Cystone
Uricare
Computerized tomography
Kidney calculi
 Supersaturation
Nephrolithiasis
Quantitative CT
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Cystinuria
Kidney Diseases
Urologic Diseases
Urolithiasis
 Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Genetic Diseases, Inborn