NCT00381849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 6, 2012

Completed
Last Updated

February 4, 2016

Status Verified

January 1, 2016

Enrollment Period

3.4 years

First QC Date

September 27, 2006

Results QC Date

April 12, 2011

Last Update Submit

January 4, 2016

Conditions

CystinuriaNephrolithiasis, Calcium Oxalate

Keywords

CystoneUricareComputerized tomographyKidney calculiSupersaturationNephrolithiasisQuantitative CT

Outcome Measures

Primary Outcomes (6)

  • 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)

    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.

    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)

    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.

    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)

    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.

    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

    Agatston results are a measure of calcium typically used for measuring coronary artery calcification.

    Baseline, approximately 52 weeks after baseline

  • Volume of Kidney Stones as Measured on Computerized Tomography

    Measurement of kidney stone volume in cubic millimeters.

    Baseline, approximately 52 weeks after baseline

Secondary Outcomes (1)

  • Change in Stone Burden as Assessed by Radiologist at One Year

    Baseline, approximately 52 weeks after baseline

Study Arms (3)

Cystone then sugar pill

ACTIVE COMPARATOR

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: CystoneDrug: Sugar Pill (Placebo)

Sugar pill then Cystone

PLACEBO COMPARATOR

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

Drug: CystoneDrug: Sugar Pill (Placebo)

Open-label Cystone

EXPERIMENTAL

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

Drug: Cystone

Interventions

CystoneDRUG

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.

Also known as: Uricare
Cystone then sugar pillOpen-label CystoneSugar pill then Cystone
Sugar Pill (Placebo)DRUG

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

Cystone then sugar pillSugar pill then Cystone

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Abdollahiasl A, Kebriaeezadeh A, Nikfar S, Farshchi A, Ghiasi G, Abdollahi M. Patterns of antibiotic consumption in Iran during 2000-2009. Int J Antimicrob Agents. 2011 May;37(5):489-90. doi: 10.1016/j.ijantimicag.2011.01.022. Epub 2011 Mar 17. No abstract available.

    PMID: 21419606RESULT

  • Erickson SB, Vrtiska TJ, Canzanello VJ, Lieske JC. Cystone(R) for 1 year did not change urine chemistry or decrease stone burden in cystine stone formers. Urol Res. 2011 Jun;39(3):197-203. doi: 10.1007/s00240-010-0334-x. Epub 2010 Dec 16.

    PMID: 21161651RESULT

MeSH Terms

Conditions

CystinuriaNephrolithiasis, Calcium OxalateKidney CalculiNephrolithiasis

Interventions

cystoneSugars

Condition Hierarchy (Ancestors)

Renal AminoaciduriasRenal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrolithiasisUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

There were no serious adverse events and no adverse events. Power of the study was diminished by failure of patients to return all required 24 hour urine samples. The botanical authenticity of Cystone was not documented.

Results Point of Contact

Title
Beverly Tietje, Study Coordinator
Organization
Mayo Clinic
tietje.beverly@mayo.edu
507-255-0401

Study Officials

  • Stephen B. Erickson, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 28, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2009

Study Completion

June 1, 2010

Last Updated

February 4, 2016

Results First Posted

August 6, 2012

Record last verified: 2016-01

Locations

US(1)