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

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT03258190

Collaborator

Sanpasitthiprasong Hospital (Other), Burapha University (Other)

137

Enrollment

Location

Arms

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis	Drug: Lime Powder Regimen	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control trialRandomized control trial

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lime Powder Regimen Participants were asked to take LPR twice a day for 6 months	Drug: Lime Powder Regimen LPR and placebo were randomly given to subjects for 6 months Other Names: LPR supplement
Placebo Comparator: Placebo Participants were asked to take Placebo twice a day for 6 months	Drug: Lime Powder Regimen LPR and placebo were randomly given to subjects for 6 months Other Names: LPR supplement

Arm

Intervention/Treatment

Experimental: Lime Powder Regimen

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

Drug: Lime Powder Regimen

LPR and placebo were randomly given to subjects for 6 months

Other Names:

LPR supplement

Placebo Comparator: Placebo

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

Drug: Lime Powder Regimen

LPR and placebo were randomly given to subjects for 6 months

Other Names:

LPR supplement

Outcome Measures

Primary Outcome Measures

Renal stone recurrence [6 months]
The stone recurrence after surgical removal of stone that can be detected by CT scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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