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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

LPR and Placebo were prepared in the same containers with code that was provided by investigators

Study Groups

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Lime Powder Regimen

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

Group Type EXPERIMENTAL

Lime Powder Regimen

Intervention Type DRUG

LPR and placebo were randomly given to subjects for 6 months

Placebo

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

Group Type PLACEBO_COMPARATOR

Lime Powder Regimen

Intervention Type DRUG

LPR and placebo were randomly given to subjects for 6 months

Interventions

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Lime Powder Regimen

LPR and placebo were randomly given to subjects for 6 months

Intervention Type DRUG

Other Intervention Names

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LPR supplement

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No