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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03258190
Other study ID # LPR0001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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