Status:
COMPLETED
Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Himalaya Herbal Healthcare
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystinuria
Nephrolithiasis, Calcium Oxalate
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
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. Cyst...
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 contro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00381849
Start Date
April 1 2006
End Date
June 1 2010
Last Update
February 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905