Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Renal stone recurrence
研究概览
简要总结
Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.
详细描述
Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
LPR and Placebo were prepared in the same containers with code that was provided by investigators
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal stone patients who were identified and stone was removed by surgical method.
排除标准
- •Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
研究组 & 干预措施
Lime Powder Regimen
Participants were asked to take LPR twice a day for 6 months
干预措施: Lime Powder Regimen (Drug)
Placebo
Participants were asked to take Placebo twice a day for 6 months
干预措施: Lime Powder Regimen (Drug)
结局指标
主要结局
Renal stone recurrence
时间窗: 6 months
The stone recurrence after surgical removal of stone that can be detected by CT scan
次要结局
未报告次要终点
研究者
Piyaratana Tosukhowong
Professor
Chulalongkorn University