UrolithiasisPhase 2NCT03258190
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
A Phase 2 study testing Lime Powder Regimen in people with Urolithiasis, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Lime Powder Regimen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2014to 30 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal stone patients who were identified and stone was removed by surgical method.
Who cannot join
- Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
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
- Urolithiasis
- Being tested
- Lime Powder Regimen
- Keywords
- Urolithiasis, Recurrence, Citrate, Antioxidants, Lime Powder Regimen
- Medical subject headings
- Urolithiasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lime Powder RegimenDrug
Also called LPR supplement
LPR and placebo were randomly given to subjects for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Lime Powder Regimen | Experimental | Participants were asked to take LPR twice a day for 6 months Receives: Drug: Lime Powder Regimen |
| Placebo | Placebo comparator | Participants were asked to take Placebo twice a day for 6 months Receives: Drug: Lime Powder Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal stone recurrence
The stone recurrence after surgical removal of stone that can be detected by CT scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Jul 2014
- Primary completion1 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanpasitthiprasong Hospital, Burapha University
- Responsible party
- Principal investigator, Piyaratana Tosukhowong, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258190
- Sponsor's protocol ID
- LPR0001
- Status last verified
- Jan 2019
- First submitted
- 20 Aug 2017
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.
- ClinicalTrials.gov ID
- NCT03258190
- Acronym / sponsor ID
- LPR0001
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, Recurrence, Citrate, Antioxidants, Lime Powder Regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Sanpasitthiprasong Hospital, Burapha University
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Lime Powder Regimen | Experimental | Drug: Lime Powder RegimenParticipants were asked to take LPR twice a day for 6 months |
| Placebo | Placebo comparator | Drug: Lime Powder RegimenParticipants were asked to take Placebo twice a day for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Renal stone patients who were identified and stone was removed by surgical method.
Key exclusion criteria (1 listed)
- Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lime Powder RegimenAlso: LPR supplementLPR and placebo were randomly given to subjects for 6 months | Drug | Lime Powder Regimen, Placebo |
Primary outcome
Renal stone recurrence
Time frame: 6 months
The stone recurrence after surgical removal of stone that can be detected by CT scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Results publication: PubMed 25588323Chariyavilaskul 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.
- Clinical trial phase 1Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lime Powder Regimen in people with Urolithiasis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal stone recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.