NCT03258190

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

August 20, 2017

Last Update Submit

January 30, 2019

Conditions

Keywords

UrolithiasisRecurrenceCitrateAntioxidantsLime Powder Regimen

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

EXPERIMENTAL

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

Drug: Lime Powder Regimen

Placebo

PLACEBO COMPARATOR

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

Drug: Lime Powder Regimen

Interventions

LPR and placebo were randomly given to subjects for 6 months

Also known as: LPR supplement
Lime Powder RegimenPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

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.

Related Links

MeSH Terms

Conditions

UrolithiasisRecurrence

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Model Details: Randomized control trial
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

Locations