CompletedNCT03258190Updated Feb 1, 2019

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

A Phase 2 interventional study of Lime Powder Regimen in Urolithiasis, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Chulalongkorn University · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 137
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Urolithiasis

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Keywords

Urolithiasis
Recurrence
Citrate
Antioxidants
Lime Powder Regimen

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Renal stone patients who were identified and stone was removed by surgical method.

Exclusion criteria

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

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 137 participants (actual)

Study arms

Experimental
Lime Powder Regimen
Participants were asked to take LPR twice a day for 6 months
Drug: Lime Powder Regimen
Placebo comparator
Placebo
Participants were asked to take Placebo twice a day for 6 months
Drug: Lime Powder Regimen

Interventions

DrugLime Powder Regimen
LPR and placebo were randomly given to subjects for 6 months
Also known as: LPR supplement

What researchers measure

Primary outcomes

Renal stone recurrence
The stone recurrence after surgical removal of stone that can be detected by CT scan
Time frame: 6 months

Study locations

1 site

Chulalongkorn University
Bangkok, 10330, Thailand

References and documents

Publications

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 volunteers. Urolithiasis. 2015 Apr;43(2):125-34. doi: 10.1007/s00240-015-0751-y. Epub 2015 Jan 15. PubMed 25588323 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03258190
Lead sponsor: Chulalongkorn University
Collaborators: Sanpasitthiprasong Hospital, Burapha University
Responsible party: Piyaratana Tosukhowong (Professor, Chulalongkorn University) — Principal investigator
First posted: Aug 23, 2017
Start date: Jul 1, 2014
Primary completion: Jun 1, 2018
Completion: Jun 30, 2018
Last update: Feb 1, 2019

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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