Urolithiasis
Conditions
Keywords
Urolithiasis, Recurrence, Citrate, Antioxidants, Lime Powder Regimen
Brief summary
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.
Detailed description
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.
Interventions
DRUGLime Powder Regimen
LPR and placebo were randomly given to subjects for 6 months
Sponsors
Sanpasitthiprasong Hospital
Burapha University
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
LPR and Placebo were prepared in the same containers with code that was provided by investigators
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Renal stone patients who were identified and stone was removed by surgical method.
Exclusion criteria
* Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal stone recurrence | 6 months | The stone recurrence after surgical removal of stone that can be detected by CT scan |
Countries
Thailand
Outcome results
None listed