<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/NCT02237989</url>
  </required_header>
  <id_info>
    <org_study_id>FY2001</org_study_id>
    <nct_id>NCT02237989</nct_id>
  </id_info>
  <brief_title>Effects Of Native Collagen Type 2 Treatment</brief_title>
  <official_title>Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir Osmangazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eskisehir Osmangazi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint&#xD;
      pain and function and its effects on urinary biological markers related to cartilage&#xD;
      degeneration in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group&#xD;
      includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients&#xD;
      given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three&#xD;
      months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster&#xD;
      Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36),&#xD;
      Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)</measure>
    <time_frame>3 months</time_frame>
    <description>Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score</measure>
    <time_frame>3 months</time_frame>
    <description>Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Change From Baseline in 20 Meters Walking Time</measure>
    <time_frame>3 months</time_frame>
    <description>Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Change From Baseline in Short Form 36 / Bodily Pain Subgroup</measure>
    <time_frame>3 months</time_frame>
    <description>Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Change From Baseline in Coll2-1 Levels</measure>
    <time_frame>3 months</time_frame>
    <description>Post treatment comparison of Coll2-1 levels between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>native collagen type 2 + paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>1500 mg</description>
    <arm_group_label>paracetamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol+native collagen type 2</intervention_name>
    <description>paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
    <arm_group_label>native collagen type 2 + paracetamol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Patients aged 45-70 years with the diagnosis of primary knee OA&#xD;
        according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence&#xD;
        radiological stage II or III and knee pain -&#xD;
&#xD;
        Exclusion Criteria:Patients with intraarticular injections or physical therapy within the&#xD;
        last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin&#xD;
        or other natural health products within the last month, serious concomitant systemic&#xD;
        diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or&#xD;
        se¬vere cardiac, renal, hepatic, hematologic disease&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fulya Bakilan, Specialist</last_name>
    <role>Study Director</role>
    <affiliation>Yerkoy State Hospital</affiliation>
  </overall_official>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>September 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 18, 2020</results_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>Onur Armağan</investigator_full_name>
    <investigator_title>Onur Armagan, Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>knee osteoarthritis, native collagen type 2, paracetamol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Paracetamol</title>
          <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
        </group>
        <group group_id="P2">
          <title>Native Collagen Type 2 + Paracetamol</title>
          <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Paracetamol</title>
          <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
        </group>
        <group group_id="B2">
          <title>Native Collagen Type 2 + Paracetamol</title>
          <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.84" spread="6.55"/>
                    <measurement group_id="B2" value="57.65" spread="8.73"/>
                    <measurement group_id="B3" value="58.2" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)</title>
        <description>Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol</title>
            <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
          </group>
          <group group_id="O2">
            <title>Native Collagen Type 2 + Paracetamol</title>
            <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)</title>
          <description>Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="9"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score</title>
        <description>Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol</title>
            <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
          </group>
          <group group_id="O2">
            <title>Native Collagen Type 2 + Paracetamol</title>
            <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score</title>
          <description>Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52" lower_limit="24" upper_limit="100"/>
                    <measurement group_id="O2" value="44" lower_limit="24" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Change From Baseline in 20 Meters Walking Time</title>
        <description>Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol</title>
            <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
          </group>
          <group group_id="O2">
            <title>Native Collagen Type 2 + Paracetamol</title>
            <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in 20 Meters Walking Time</title>
          <description>Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.84" spread="4.79"/>
                    <measurement group_id="O2" value="18" spread="3.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Change From Baseline in Short Form 36 / Bodily Pain Subgroup</title>
        <description>Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol</title>
            <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
          </group>
          <group group_id="O2">
            <title>Native Collagen Type 2 + Paracetamol</title>
            <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in Short Form 36 / Bodily Pain Subgroup</title>
          <description>Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better</description>
          <units>score</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="10" upper_limit="100"/>
                    <measurement group_id="O2" value="52" lower_limit="10" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Change From Baseline in Coll2-1 Levels</title>
        <description>Post treatment comparison of Coll2-1 levels between groups</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Paracetamol</title>
            <description>The 1st group includes 19 patients given 1500mg/day paracetamol for three months&#xD;
paracetamol: 1500 mg</description>
          </group>
          <group group_id="O2">
            <title>Native Collagen Type 2 + Paracetamol</title>
            <description>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months&#xD;
paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg)</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in Coll2-1 Levels</title>
          <description>Post treatment comparison of Coll2-1 levels between groups</description>
          <units>microgram/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130" lower_limit="22.4" upper_limit="596.13"/>
                    <measurement group_id="O2" value="155.25" lower_limit="26.84" upper_limit="558.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>1500 mg/day acetaminophen and 10 mg/day of native type II collagen</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>1500 mg/day acetaminophen</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Fulya Bakılan</name_or_title>
      <organization>Eskisehir Osmangazi University</organization>
      <phone>+905057737335</phone>
      <email>fulyabakilan@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02237989
org study id: FY2001
nct id: NCT02237989
lead sponsor: 
has dmc: No
The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint
      pain and function and its effects on urinary biological markers related to cartilage
      degeneration in patients with knee osteoarthritis.
39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group
      includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients
      given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three
      months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster
      Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36),
      Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
time frame: 3 months
description: Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.
measure: the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
time frame: 3 months
description: Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.
measure: the Change From Baseline in 20 Meters Walking Time
time frame: 3 months
description: Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses
measure: the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
time frame: 3 months
description: Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better
measure: the Change From Baseline in Coll2-1 Levels
time frame: 3 months
description: Post treatment comparison of Coll2-1 levels between groups
arm group label: paracetamol
arm group type: Active Comparator
description: The 1st group includes 19 patients given 1500mg/day paracetamol for three months
arm group label: native collagen type 2 + paracetamol
arm group type: Experimental
description: The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
intervention type: Drug
intervention name: paracetamol
description: 1500 mg
arm group label: paracetamol
intervention type: Drug
intervention name: paracetamol+native collagen type 2
description: paracetamol (1500 mg) + native collagen type 2 (10mg)
arm group label: native collagen type 2 + paracetamol
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fulya Bakilan, Specialist
role: Study Director
affiliation: Yerkoy State Hospital
responsible party type: Principal Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: Onur Armağan
investigator title: Onur Armagan, Medical Doctor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Acetaminophen
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 