Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

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.

Timeline

Start

2006-04

Primary completion

2009-09

Completion

2010-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Calcium Stone Subjects; p = 0.32; t-test, 1 sided NCT00381849 ↗

registry analysis (superiority or other test); Calcium Stone Subjects; p = 0.49; t-test, 1 sided NCT00381849 ↗

registry analysis (superiority or other test); Cystine Stone Subjects; p = 0.69; t-test, 1 sided NCT00381849 ↗

registry analysis (superiority or other test); Calcium Stone Subjects; p = 0.85; t-test, 2 sided NCT00381849 ↗

registry analysis (superiority or other test); Calcium Stone Subjects; p = 0.81; t-test, 2 sided NCT00381849 ↗

Publications

• Results 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.
• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cystone	Traditional medicine (herbal / TCM)	—	—

Indications