Phase 2 Completed N=20 Randomized Double-blind Treatment

Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

Cystinuria · Nephrolithiasis, Calcium Oxalate

Source: ClinicalTrials.gov NCT00381849 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcomePrimary: 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx) — 1.83; 1.83; 1.87; 1.78 KJoules/mol — p=0.32

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)	1.83; 1.83; 1.87; 1.78	0.32
PRIMARY 24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)	0.35; 0.73; 0.38; 0.09	0.49
PRIMARY 24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)	4.25; 5.03; 4.65; 4.09	—
PRIMARY 24 Hour Urinary Cystine Excretion	2770; 3183; 2948; 4140	0.69
PRIMARY Stone Density as Measured by Agatston Score Via Computerized Tomography	49.75; 2,107; 56.13; 2,183; 166.13; 383	0.85
PRIMARY Volume of Kidney Stones as Measured on Computerized Tomography	45.5; 1,602; 52.75; 1,677; 141.25; 301	0.81
SECONDARY Change in Stone Burden as Assessed by Radiologist at One Year	6; 7; 2; 2; 1; 0	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00381849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.