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Completed

NCT Number: NCT00381849

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

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.

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Key information

Conditions

Cystinuria Calculi Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nephrolithiasis, Calcium Oxalate Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Aminoacidurias Renal Tubular Transport, Inborn Errors Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cystone

Drug

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 names: Uricare

Sugar Pill (placebo)

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Cystone for Treatment of Nephrolithiasis

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Sep 28, 2006
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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