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Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

2014-08-27 03:42:19 | BioPortfolio

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 58 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. The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by CT scanning.

Description

Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Cystinurics 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 48 weeks. Entry and final stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Cystinuria

Intervention

Cystone

Location

Mayo Clinic
Rochester
Minnesota
United States
55905

Status

Active, not recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:19-0400

Clinical Trials [6 Associated Clinical Trials listed on BioPortfolio]

TCUPS- Tolvaptan Use in Cyctinuria and Urolithiasis: A Pilot Study

The goal of this research project is to establish that in short-term use, tolvaptan is a safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot study o...

Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria

The purpose of this study is to determine the minimum effective dose of the cysteine binding thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine solubility...

Rare Kidney Stone Consortium Patient Registry

The purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria (PH), Dent disease, Cystinuria and APRT de...

Biobank Protocol, Rare Diseases Clinical Research Network

This study is being done to obtain samples from patients with primary hyperoxaluria, cystinuria, adenine phosphoribosyl transferase (APRT) deficiency, and Dent disease, and from their fami...

Prospective Research Rare Kidney Stones (ProRKS)

The purpose of this study is to determine the natural history of the hereditary forms of nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria, Dent dise...

PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

First cardiac manifestation of hypotonia-cystinuria syndrome.

Hypotonia-cystinuria syndrome is a very rare autosomal recessive contiguous gene deletion syndrome of PREPL and SLC3A1 at 2p21 with neuromuscular and neuroendocrinologic presentation. We report a two-...

The impact of surgical intervention on renal function in cystinuria.

Cystinuria is an autosomal recessive disorder due to intestinal and renal transport defects in cystine and dibasic amino acids, which result in recurrent urolithiasis and surgical interventions. This ...

Causality between myopathic hypotonia-cystinuria syndrome (HCS) and noncompaction (LVHT) is not compelling.

Conversion from Cystine to Non-cystine Stones: Incidence and Associated Factors.

and Objectives: Cystinuric patients are often treated with medical alkanalization and shockwave lithotripsy - both are hypothesized to increase the risk of calcium phosphate stones. We performed a mul...

Simultaneous determination of tiopronin and its primary metabolite in plasma and ocular tissues by HPLC.

Tiopronin, formally 2-mercaptopropionylglycine (MPG), is currently prescribed to treat cystinuria and rheumatoid arthritis, and its antioxidant properties have led to its investigation as a treatment ...

Medical and Biotech [MESH] Definitions

An inherited disorder due to defective reabsorption of CYSTINE and other BASIC AMINO ACIDS by the PROXIMAL RENAL TUBULES. This form of aminoaciduria is characterized by the abnormally high urinary levels of cystine; LYSINE; ARGININE; and ORNITHINE. Mutations involve the amino acid transport protein gene SLC3A1.

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