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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258190
• Other study ID #: LPR0001
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 30, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Urolithiasis

Intervention

Drug:
• Lime Powder Regimen
LPR and placebo were randomly given to subjects for 6 months

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Chulalongkorn University	Burapha University, Sanpasitthiprasong Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Chariyavilaskul P, Poungpairoj P, Chaisawadi S, Boonla C, Dissayabutra T, Prapunwattana P, Tosukhowong P. In vitro anti-lithogenic activity of lime powder regimen (LPR) and the effect of LPR on urinary risk factors for kidney stone formation in healthy vo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal stone recurrence	The stone recurrence after surgical removal of stone that can be detected by CT scan	6 months

External Links

•   Clinical trial phase 1