Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
Condition: Cystinuria; Nephrolithiasis, Calcium Oxalate
MeSH terms: Nephrolithiasis; Kidney Calculi; Cystinuria
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Cystone; Sugar Pill (Placebo)
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Participants will take 2 pills, 2 times a day for 6 weeks.
Other intervention name(s): Uricare
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cystone; Uricare; Computerized tomography; Kidney calculi; Supersaturation; Nephrolithiasis; Quantitative CT