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

Chulalongkorn University

Status and phase: Completed; Phase 2

Conditions: Urolithiasis

Treatments: Drug: Lime Powder Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03258190

LPR0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 2 patient groups, including a placebo group

Lime Powder Regimen

Experimental group

Description:

Participants were asked to take LPR twice a day for 6 months

Treatment:

Drug: Lime Powder Regimen

Placebo

Placebo Comparator group

Description:

Participants were asked to take Placebo twice a day for 6 months

Treatment:

Drug: Lime Powder Regimen