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Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence

Phase 2
Completed
Conditions
Urolithiasis
Interventions
Registration Number
NCT03258190
Lead Sponsor
Chulalongkorn University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
137
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboLime Powder RegimenParticipants were asked to take Placebo twice a day for 6 months
Lime Powder RegimenLime Powder RegimenParticipants were asked to take LPR twice a day for 6 months
Primary Outcome Measures
NameTimeMethod
Renal stone recurrence6 months

The stone recurrence after surgical removal of stone that can be detected by CT scan

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Chulalongkorn University

🇹🇭

Bangkok, Thailand

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