<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/NCT03016039</url>
  </required_header>
  <id_info>
    <org_study_id>0210-16-MMC</org_study_id>
    <nct_id>NCT03016039</nct_id>
  </id_info>
  <brief_title>Curcumin Supplementation for Gynecological Diseases</brief_title>
  <official_title>Curcumin Supplementation for Gynecological Diseases Including Pelvic Inflammatory Disease Endometritis, Endometriosis: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To use curcumin supplementation as an additive treatment to induce clinical, biochemical&#xD;
      response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian&#xD;
      abcess, Endometritis, wound infection.&#xD;
&#xD;
      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection&#xD;
      patients may augment clinical and biochemical response and accelerates the improvements of&#xD;
      the sign symptoms and reported outcomes of those diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic inflammatory disease (PID), Endometritis, Wound infection are infections of the female&#xD;
      reproductive system. Although PID is a well known pathophysiology the diagnosis method I not&#xD;
      well established and its true magnitude is unknown. Many women report that they have been&#xD;
      treated for PID when they did not suffer from it and vice versa. Hence the main way to&#xD;
      diagnose remains clinical and currently there is no well-established biochemical marker. In&#xD;
      endometritis and wound infection the cause may be known but the pathogens involved in the&#xD;
      disease formation vary as for this broad spectrum antibiotic is needed.&#xD;
&#xD;
      Aims: To use curcumin supplementation as an additive treatment to induce clinical,&#xD;
      biochemical response and remission in patients with suspected PID, Tubo ovarian abcess,&#xD;
      Endometritis, wound infection.&#xD;
&#xD;
      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection&#xD;
      patients may augment clinical and biochemical response and accelerates the improvements of&#xD;
      the sign symptoms and reported outcomes of those diseases.&#xD;
&#xD;
      Rational: Curcumin treatment has been shown to safe and efficient in inflammatory states such&#xD;
      as in mild-moderate Ulcerative colitis (UC), obesity, and type II diabetes mellitus when used&#xD;
      as an add-on to conventional treatment.&#xD;
&#xD;
      In the gynecology and especially in the PID/Tubo ovarian abcess diseases the use of Curcumin&#xD;
      as a supplement has never been studied.&#xD;
&#xD;
      In the future it is necessary to study the use of curcumin in different gynecological&#xD;
      diseases (e.g Endometriosis/Premenstrual syndrome (PMS) and also in gynecology oncology) in&#xD;
      which inflammatory and immune response are involve in the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 7, 2017</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Change in the Levels of C reactive protein</measure>
    <time_frame>at recruitment and after two week and after one month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Levels of White blood cells</measure>
    <time_frame>at recruitment and after two week and after one month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Curcumin Use for Gynecological Conditions</condition>
  <arm_group>
    <arm_group_label>Dietary supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive Dietary supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>conventional Antibiotic treatment without curcumin supplementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Curcumin supplementation</intervention_name>
    <description>use of curcumin supplementation as an additive treatment to the conventional treatment</description>
    <arm_group_label>Dietary supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18&#xD;
&#xD;
          -  The patient was admitted with a diagnosis of Pelvic inflammatory disease / Tubo&#xD;
             ovarian abcess, surgical wound infection, Endometritis&#xD;
&#xD;
          -  No Antibiotic treatment was given prior to her recruitment for the study&#xD;
&#xD;
          -  The women is not in menopause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 and above 52&#xD;
&#xD;
          -  Antibiotic treatment was given prior to her recruitment for the study&#xD;
&#xD;
          -  The women is in menopause&#xD;
&#xD;
          -  Pregnant women. Known other inflammatory disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nissim ARBIB, MD</last_name>
    <phone>0097297471783</phone>
    <email>Nisim.Arbib@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir hospital</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nissim Arbib, MD</last_name>
      <phone>0097297471783</phone>
      <email>Nisim.Arbib@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>October 11, 2020</last_update_submitted>
  <last_update_submitted_qc>October 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 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>Genital Diseases, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Curcumin</mesh_term>
  </intervention_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/NCT03016039
org study id: 0210-16-MMC
nct id: NCT03016039
lead sponsor: 
has dmc: Yes
To use curcumin supplementation as an additive treatment to induce clinical, biochemical
      response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian
      abcess, Endometritis, wound infection.

      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection
      patients may augment clinical and biochemical response and accelerates the improvements of
      the sign symptoms and reported outcomes of those diseases.
Pelvic inflammatory disease (PID), Endometritis, Wound infection are infections of the female
      reproductive system. Although PID is a well known pathophysiology the diagnosis method I not
      well established and its true magnitude is unknown. Many women report that they have been
      treated for PID when they did not suffer from it and vice versa. Hence the main way to
      diagnose remains clinical and currently there is no well-established biochemical marker. In
      endometritis and wound infection the cause may be known but the pathogens involved in the
      disease formation vary as for this broad spectrum antibiotic is needed.

      Aims: To use curcumin supplementation as an additive treatment to induce clinical,
      biochemical response and remission in patients with suspected PID, Tubo ovarian abcess,
      Endometritis, wound infection.

      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection
      patients may augment clinical and biochemical response and accelerates the improvements of
      the sign symptoms and reported outcomes of those diseases.

      Rational: Curcumin treatment has been shown to safe and efficient in inflammatory states such
      as in mild-moderate Ulcerative colitis (UC), obesity, and type II diabetes mellitus when used
      as an add-on to conventional treatment.

      In the gynecology and especially in the PID/Tubo ovarian abcess diseases the use of Curcumin
      as a supplement has never been studied.

      In the future it is necessary to study the use of curcumin in different gynecological
      diseases (e.g Endometriosis/Premenstrual syndrome (PMS) and also in gynecology oncology) in
      which inflammatory and immune response are involve in the disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Levels of C reactive protein
time frame: at recruitment and after two week and after one month
measure: Change in the Levels of White blood cells
time frame: at recruitment and after two week and after one month
arm group label: Dietary supplementation
arm group type: Experimental
description: This group will receive Dietary supplementation
arm group label: conventional treatment
arm group type: No Intervention
description: conventional Antibiotic treatment without curcumin supplementation
intervention type: Dietary Supplement
intervention name: Curcumin supplementation
description: use of curcumin supplementation as an additive treatment to the conventional treatment
arm group label: Dietary supplementation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 52 Years
healthy volunteers: No
last name: Nissim ARBIB, MD
phone: 0097297471783
email: Nisim.Arbib@clalit.org.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Genital Diseases, Female
mesh term: Curcumin
sharing ipd: No