Use of Lapis Judaicus to Dissolve Kidney Stones
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stone size after 12 weeks
研究概览
简要总结
The investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. End points are changes in urinary chemistries and stone burden by Ultra sonography / CT scan.
It will be used in proven calcium stone forming adults who are not pregnant. This phase is a double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine supersaturations, pH and sodium determinations will be collected. Entry and final stone quantification Ultra sonography / CT scan will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over
- •Mentally competent
- •Medically effective birth control if fertile female
- •History of calcium containing stone AND current quantifiable stone
- •Able to comply with protocol
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Lapis judaicus
干预措施: Lapis Judaicus (Drug)
结局指标
主要结局
Stone size after 12 weeks
时间窗: 8 weeks and 12 weeks
24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT
次要结局
未报告次要终点
研究者
Pouya Faridi
Principal Investigator
Shiraz University of Medical Sciences