Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cystinuria, Nephrolithiasis, Calcium Oxalate
In brief
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.
Key facts
- Study ID
- NCT00381849
- Run by
- Mayo Clinic
- People needed
- 20
- Starts
- 2006-04-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2016-02-04
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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