<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03258190</url>
  </required_header>
  <id_info>
    <org_study_id>LPR0001</org_study_id>
    <nct_id>NCT03258190</nct_id>
  </id_info>
  <brief_title>Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence</brief_title>
  <official_title>Lime Powder Regimen Supplement Alleviates Urinary Metabolic Abnormalities to Prevent Urolithiasis Recurrence.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanpasitthiprasong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Burapha University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and&#xD;
      potassium. LPR was invented to treat the renal stone patients with high risk of stone&#xD;
      recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse&#xD;
      effect than current standard medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing&#xD;
      high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants.&#xD;
      LPR was tested and verified to be very less toxic in cell culture and animal models. The&#xD;
      clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance&#xD;
      stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of&#xD;
      LPR was very low.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized control trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>LPR and Placebo were prepared in the same containers with code that was provided by investigators</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Renal stone recurrence</measure>
    <time_frame>6 months</time_frame>
    <description>The stone recurrence after surgical removal of stone that can be detected by CT scan</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Lime Powder Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were asked to take LPR twice a day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants were asked to take Placebo twice a day for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lime Powder Regimen</intervention_name>
    <description>LPR and placebo were randomly given to subjects for 6 months</description>
    <arm_group_label>Lime Powder Regimen</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>LPR supplement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Renal stone patients who were identified and stone was removed by surgical method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic kidney disease, chronic liver disease, history of coronary artery disease, or&#xD;
             person who takes any medication that alters urinary metabolic profiles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <link>
    <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</url>
    <description>Clinical trial phase 1</description>
  </link>
  <results_reference>
    <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.</citation>
    <PMID>25588323</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Piyaratana Tosukhowong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Urolithiasis</keyword>
  <keyword>Recurrence</keyword>
  <keyword>Citrate</keyword>
  <keyword>Antioxidants</keyword>
  <keyword>Lime Powder Regimen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258190
org study id: LPR0001
nct id: NCT03258190
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial
primary purpose: Prevention
masking: Single (Participant)
masking description: LPR and Placebo were prepared in the same containers with code that was provided by investigators
measure: Renal stone recurrence
time frame: 6 months
description: The stone recurrence after surgical removal of stone that can be detected by CT scan
arm group label: Lime Powder Regimen
arm group type: Experimental
description: Participants were asked to take LPR twice a day for 6 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants were asked to take Placebo twice a day for 6 months
intervention type: Drug
intervention name: Lime Powder Regimen
description: LPR and placebo were randomly given to subjects for 6 months
arm group label: Lime Powder Regimen
arm group label: Placebo
other name: LPR supplement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Thailand
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
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.
PMID: 25588323
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Piyaratana Tosukhowong
investigator title: Professor
mesh term: Urolithiasis
mesh term: Urinary Calculi
mesh term: Recurrence
sharing ipd: No