<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/NCT02263378</url>
  </required_header>
  <id_info>
    <org_study_id>OASIT-K</org_study_id>
    <nct_id>NCT02263378</nct_id>
  </id_info>
  <brief_title>A New Supplement for the Immune Response to HPV Infection</brief_title>
  <official_title>Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Messina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Messina</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether a supplement in which ellagic acid plus&#xD;
      annona muricata are combined, may modulate the immune response to high risk HPV infection.&#xD;
      Sixty women will be enrolled in a randomized, controlled study, having a histological&#xD;
      diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the&#xD;
      activation of onco suppressor protein by the supplement and secondary outcome is the&#xD;
      clearance of HPV infection in the treated group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clearance of the HPV infection</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>HPV Infection</condition>
  <arm_group>
    <arm_group_label>supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>not intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ellagic acid + annona muricata</intervention_name>
    <description>pills</description>
    <arm_group_label>not intervention</arm_group_label>
    <arm_group_label>supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with high risk HPV infection&#xD;
&#xD;
          -  histological diagnosis of L-SIL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with no high risk HPV infection&#xD;
&#xD;
          -  women without histological diagnosis of L-SIL&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>May 23, 2016</last_update_submitted>
  <last_update_submitted_qc>May 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Messina</investigator_affiliation>
    <investigator_full_name>Rosario D'anna</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>HPV, L-SIL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Papillomavirus Infections</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/NCT02263378
org study id: OASIT-K
nct id: NCT02263378
lead sponsor: 
The purpose of this study is to evaluate whether a supplement in which ellagic acid plus
      annona muricata are combined, may modulate the immune response to high risk HPV infection.
      Sixty women will be enrolled in a randomized, controlled study, having a histological
      diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the
      activation of onco suppressor protein by the supplement and secondary outcome is the
      clearance of HPV infection in the treated group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells
time frame: 6 months
measure: clearance of the HPV infection
time frame: 6 months
arm group label: supplement
arm group type: Experimental
arm group label: not intervention
arm group type: Placebo Comparator
intervention type: Drug
intervention name: ellagic acid + annona muricata
description: pills
arm group label: not intervention
arm group label: supplement
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Messina
investigator full name: Rosario D'anna
investigator title: associate professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Papillomavirus Infections