Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
1 other identifier
interventional
137
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFebruary 1, 2019
January 1, 2019
3.9 years
August 20, 2017
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal stone recurrence
The stone recurrence after surgical removal of stone that can be detected by CT scan
6 months
Study Arms (2)
Lime Powder Regimen
EXPERIMENTALParticipants were asked to take LPR twice a day for 6 months
Placebo
PLACEBO COMPARATORParticipants were asked to take Placebo twice a day for 6 months
Interventions
LPR and placebo were randomly given to subjects for 6 months
Eligibility Criteria
You may qualify if:
- Renal stone patients who were identified and stone was removed by surgical method.
You may not qualify if:
- Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chulalongkorn Universitylead
- Sanpasitthiprasong Hospitalcollaborator
- Burapha Universitycollaborator
Study Sites (1)
Chulalongkorn University
Bangkok, 10330, Thailand
Related 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 volunteers. Urolithiasis. 2015 Apr;43(2):125-34. doi: 10.1007/s00240-015-0751-y. Epub 2015 Jan 15.
PMID: 25588323RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- LPR and Placebo were prepared in the same containers with code that was provided by investigators
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 20, 2017
First Posted
August 23, 2017
Study Start
July 1, 2014
Primary Completion
June 1, 2018
Study Completion
June 30, 2018
Last Updated
February 1, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share