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NCT00381849 · ClinicalTrials.gov registry record · Phase 1
Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00381849: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00381849 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00381849, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phase
Interventions
- DRUG Sugar Pill (Placebo)
- DRUG Cystone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00381849 record still lists
NCT00381849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Sugar Pill (Placebo) is the first listed.
NCT00381849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00381849 about?
NCT00381849 is a clinical study titled "Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones". 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 wi...
What is the current status of trial NCT00381849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-04. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00381849?
The interventions under investigation include: Sugar Pill (Placebo) (DRUG), Cystone (DRUG).
Who is sponsoring clinical trial NCT00381849?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00381849's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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