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

Primary Purpose

Urolithiasis

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Lime Powder Regimen
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urolithiasis focused on measuring Urolithiasis, Recurrence, Citrate, Antioxidants, Lime Powder Regimen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lime Powder Regimen

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Renal stone recurrence
The stone recurrence after surgical removal of stone that can be detected by CT scan

Secondary Outcome Measures

Full Information

First Posted
August 20, 2017
Last Updated
January 30, 2019
Sponsor
Chulalongkorn University
Collaborators
Sanpasitthiprasong Hospital, Burapha University
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1. Study Identification

Unique Protocol Identification Number
NCT03258190
Brief Title
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
Official Title
Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Sanpasitthiprasong Hospital, Burapha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Urolithiasis, Recurrence, Citrate, Antioxidants, Lime Powder Regimen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Participant
Masking Description
LPR and Placebo were prepared in the same containers with code that was provided by investigators
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lime Powder Regimen
Arm Type
Experimental
Arm Description
Participants were asked to take LPR twice a day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants were asked to take Placebo twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
Lime Powder Regimen
Other Intervention Name(s)
LPR supplement
Intervention Description
LPR and placebo were randomly given to subjects for 6 months
Primary Outcome Measure Information:
Title
Renal stone recurrence
Description
The stone recurrence after surgical removal of stone that can be detected by CT scan
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25588323
Citation
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.
Results Reference
result
Links:
URL
https://www-ncbi-nlm-nih-gov.cuml1.md.chula.ac.th/pubmed/?term=In+vitro+anti%E2%80%91lithogenic+activity+of+lime+powder+regimen+(LPR)+and+the+effect+of+LPR+on+urinary+risk+factors+for+kidney+stone+formation+in+healthy+volunteers
Description
Clinical trial phase 1

Learn more about this trial

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

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