xml: <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/NCT05971004</url>
    </required_header>
    <id_info>
      <org_study_id>Collagen Peptide Ligament</org_study_id>
      <nct_id>NCT05971004</nct_id>
    </id_info>
    <brief_title>Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain</brief_title>
    <official_title>Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tiss'You srl</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tiss'You srl</source>
    <oversight_info>
      <has_dmc>No</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>
        Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National&#xD;
        Hospital, the study investigates a new approach to treating persistent collateral ligament&#xD;
        pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen&#xD;
        peptide injections, a treatment that addresses pain and inflammation in ways previous methods&#xD;
        have not.&#xD;
  &#xD;
        The study involves a randomized controlled trial with 62 patients, all diagnosed with&#xD;
        inflammation in the collateral ligament site. The patients are split into two groups: one&#xD;
        receiving collagen injections alongside oral painkillers and the other receiving depo-medrol&#xD;
        injections with oral painkillers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 13, 2022</start_date>
    <completion_date type="Actual">April 4, 2023</completion_date>
    <primary_completion_date type="Actual">October 10, 2022</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>WOMAC</measure>
      <time_frame>6 months</time_frame>
      <description>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VAS (Visual Analogue Pain)</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ultrasound</measure>
      <time_frame>Baseline, 3 months, 6 months</time_frame>
      <description>Ultrasound evaluation for hypoechoic (signal reduction), normal, and hyperechoic (signal amplification) ligaments. Hypoechoic signal suggests damage or degeneration of the ligament; normal signal suggests healthy ligament tissue; hyperechoic signal suggests calcification, scar, or inflammation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Likert</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WOMAC</measure>
      <time_frame>Baseline, 3 months</time_frame>
      <description>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">62</enrollment>
    <condition>Collateral Ligament Injury of Stifle Joint</condition>
    <arm_group>
      <arm_group_label>Collagen Peptide Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cortison Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Arthrys (Collagen Peptide solution)</intervention_name>
      <description>one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point</description>
      <arm_group_label>Collagen Peptide Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Depo medrol</intervention_name>
      <description>one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.</description>
      <arm_group_label>Cortison Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age above 18 years,&#xD;
  &#xD;
            -  lateral knee pain with a duration of 3 months or longer,&#xD;
  &#xD;
            -  ultrasound evidence of inflammation of the femoral condyle attachment point,&#xD;
  &#xD;
            -  agreement to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  trauma,&#xD;
  &#xD;
            -  infection,&#xD;
  &#xD;
            -  dermatitis at the site of the inflammation,&#xD;
  &#xD;
            -  damage to surrounding knee structures,&#xD;
  &#xD;
            -  history of chronic inflammatory arthritis (such as gout or rheumatoid arthritis),&#xD;
  &#xD;
            -  local corticosteroid injection within 3 months before participating 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>Tiss'You</name>
        <address>
          <city>Domagnano</city>
          <state>RSM</state>
          <zip>47895</zip>
          <country>San Marino</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>San Marino</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tiss'You srl</investigator_affiliation>
      <investigator_full_name>Prof. Binh Luu Thi</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <keyword>Collateral Ligament Pain</keyword>
    <keyword>Knee Pain</keyword>
    <keyword>Knee Instability</keyword>
    <keyword>Sports Trauma</keyword>
    <keyword>Collagen Peptide Injections</keyword>
    <keyword>Ligament Healing</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methylprednisolone</mesh_term>
      <mesh_term>Methylprednisolone Acetate</mesh_term>
      <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
      <mesh_term>Prednisolone</mesh_term>
      <mesh_term>Prednisolone acetate</mesh_term>
      <mesh_term>Prednisolone hemisuccinate</mesh_term>
      <mesh_term>Prednisolone phosphate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971004
  org study id: Collagen Peptide Ligament
  nct id: NCT05971004
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National
        Hospital, the study investigates a new approach to treating persistent collateral ligament
        pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen
        peptide injections, a treatment that addresses pain and inflammation in ways previous methods
        have not.
  
        The study involves a randomized controlled trial with 62 patients, all diagnosed with
        inflammation in the collateral ligament site. The patients are split into two groups: one
        receiving collagen injections alongside oral painkillers and the other receiving depo-medrol
        injections with oral painkillers.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: WOMAC
  time frame: 6 months
  description: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
  measure: VAS (Visual Analogue Pain)
  time frame: Baseline, 3 months, 6 months
  description: Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain)
  measure: Ultrasound
  time frame: Baseline, 3 months, 6 months
  description: Ultrasound evaluation for hypoechoic (signal reduction), normal, and hyperechoic (signal amplification) ligaments. Hypoechoic signal suggests damage or degeneration of the ligament; normal signal suggests healthy ligament tissue; hyperechoic signal suggests calcification, scar, or inflammation.
  measure: Likert
  time frame: Baseline, 6 months
  description: Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction)
  measure: WOMAC
  time frame: Baseline, 3 months
  description: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
  arm group label: Collagen Peptide Group
  arm group type: Experimental
  description: The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle).
  arm group label: Cortison Group
  arm group type: Active Comparator
  description: The Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.
  intervention type: Device
  intervention name: Arthrys (Collagen Peptide solution)
  description: one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point
  arm group label: Collagen Peptide Group
  intervention type: Drug
  intervention name: Depo medrol
  description: one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.
  arm group label: Cortison Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: San Marino
  responsible party type: Principal Investigator
  investigator affiliation: Tiss'You srl
  investigator full name: Prof. Binh Luu Thi
  investigator title: Prof
  mesh term: Methylprednisolone
  mesh term: Methylprednisolone Acetate
  mesh term: Methylprednisolone Hemisuccinate
  mesh term: Prednisolone
  mesh term: Prednisolone acetate
  mesh term: Prednisolone hemisuccinate
  mesh term: Prednisolone phosphate
  sharing ipd: No