<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/NCT02977936</url>
  </required_header>
  <id_info>
    <org_study_id>PiL-Obs-CFort-016</org_study_id>
    <nct_id>NCT02977936</nct_id>
  </id_info>
  <brief_title>Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.</brief_title>
  <official_title>Descriptive Study for the Management of Joint Pain Associated With Osteoarthritis of the Knee: Association of Extracts of Curcuma Longa, Boswellia Serrata and Porphyra Umbilicalis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PiLeJe</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PiLeJe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts&#xD;
      of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for&#xD;
      patients suffering from gonarthritic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, 126 patients are going to be included. They will have a supplementation of&#xD;
      Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.&#xD;
&#xD;
      on the one hand, during the two visits (inclusion and follow-up), the investigator completes&#xD;
      the questionnaire about neuropathic pain (DN4).&#xD;
&#xD;
      on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4&#xD;
      times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up&#xD;
      visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal&#xD;
      Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6&#xD;
      times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just&#xD;
      before the follow-up visit (day 90).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2017</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">May 14, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients reaching the acceptability threshold of their state</measure>
    <time_frame>day 30</time_frame>
    <description>Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OASIS Score</measure>
    <time_frame>Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OASIS Score</measure>
    <time_frame>Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OASIS Score</measure>
    <time_frame>Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yes answer for the PASS</measure>
    <time_frame>Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yes answer for the PASS</measure>
    <time_frame>Day 90</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">126</enrollment>
  <condition>Gonarthrosis</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cartimotil Fort</intervention_name>
    <description>1 to 4 capsules per day during 90 days</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from gonarthrosic pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  VAS of pain : minimum 5/10 on walking or 4/10 at rest&#xD;
&#xD;
          -  Patients with a negative PASS (patient considering that the symptomatic state is not&#xD;
             acceptable)&#xD;
&#xD;
          -  Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful&#xD;
             seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen&#xD;
             scale - clinical examination)&#xD;
&#xD;
          -  Having agreed to participate in the investigation after receiving information from the&#xD;
             investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with rheumatological disorders other than osteoarthritis&#xD;
&#xD;
          -  Patients for whom knee surgery is planned within 3 months&#xD;
&#xD;
          -  Patients who started treatment with chondroitin sulphate (or all treatments of&#xD;
             osteoarthritis other than anti-inflammatories and analgesics) for less than one month&#xD;
&#xD;
          -  Patients with a BMI greater than 35&#xD;
&#xD;
          -  Patients with chronic pain that can interfere with knee osteoarthritis pain&#xD;
&#xD;
          -  Patients with reduced mobility or bedridden&#xD;
&#xD;
          -  Patients with cognitive impairments not able to participate in the study&#xD;
&#xD;
          -  Patients with known allergies to any of the ingredients of Cartimotil Fort®&#xD;
&#xD;
          -  Pregnant or breastfeeding patients&#xD;
&#xD;
          -  Patients who do not wish to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pileje Network of medical practitioners in private offices</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Arthralgia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02977936
org study id: PiL-Obs-CFort-016
nct id: NCT02977936
lead sponsor: 
has dmc: No
The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts
      of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for
      patients suffering from gonarthritic pain.
For this study, 126 patients are going to be included. They will have a supplementation of
      Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.

      on the one hand, during the two visits (inclusion and follow-up), the investigator completes
      the questionnaire about neuropathic pain (DN4).

      on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4
      times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up
      visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal
      Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6
      times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just
      before the follow-up visit (day 90).
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients reaching the acceptability threshold of their state
time frame: day 30
description: Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable).
measure: OASIS Score
time frame: Day 30
measure: OASIS Score
time frame: Day 60
measure: OASIS Score
time frame: Day 90
measure: Yes answer for the PASS
time frame: Day 60
measure: Yes answer for the PASS
time frame: Day 90
intervention type: Dietary Supplement
intervention name: Cartimotil Fort
description: 1 to 4 capsules per day during 90 days
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Arthralgia