At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 20 enrolled

Drug / intervention

Cystone +1 moredrug

Likely dose

Cystone 130 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00381849

NCT00381849Phase 2Completed

Compare CT.gov

Cystone for Treatment of Nephrolithiasis

Mayo Clinic·interventional·Posted Sep 28, 2006·Updated Feb 4, 2016

In Brief

A Phase 2 clinical trial evaluating Cystone and Sugar Pill (Placebo) for Cystinuria and Nephrolithiasis, Calcium Oxalate. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCystinuria, Nephrolithiasis, Calcium Oxalate

CountriesUnited States

CollaboratorsHimalaya Herbal Healthcare, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2006

First PostedSep 2006

Primary CompletionSep 2009

Study CompletionJun 2010

TodayJul 2026

First PostedSep 28, 2006

Enrollment StartApr 1, 2006

Primary CompletionSep 1, 2009

Study CompletionJun 1, 2010

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 19.8 years ago

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.

Sugar Pill (Placebo)drug

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