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/NCT05971680</url>
    </required_header>
    <id_info>
      <org_study_id>Vitamin B 1 IUD</org_study_id>
      <nct_id>NCT05971680</nct_id>
    </id_info>
    <brief_title>the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.</brief_title>
    <official_title>the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of&#xD;
        the IUD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be randomized controlled trial will be performed at the Obstetric and&#xD;
        Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target&#xD;
        Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology&#xD;
        department through 3 months from the start of July 2023 till the end of November 2023.&#xD;
  &#xD;
        Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in&#xD;
        accordance with a random table produced by an Excel program, with A being assigned to the&#xD;
        intervention group and B to the control group. All women will sign a written informed consent&#xD;
        prior to data collection.&#xD;
  &#xD;
        Each woman within the intervention group will receive a packet containing 30 pills (vitamin B&#xD;
        1 or placebo), each month for three months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>Phase 3</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>the duration of menstrual bleeding.</measure>
      <time_frame>3 cycles ( 3 months / one month for each cycle)</time_frame>
      <description>days of menstruation</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Intra-uterine Device Complication</condition>
    <arm_group>
      <arm_group_label>Vitamin B 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>VITAMIN B1 (High Potency) 500mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patient not subjected to treatment . only follow up</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VITAMIN B1 500mg</intervention_name>
      <description>VITAMIN B1 (High Potency) 500mg tab every day for 3 months</description>
      <arm_group_label>Vitamin B 1</arm_group_label>
      <other_name>VITAMIN B1 500mg @Biovea</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>intra-uterine contraceptive device</intervention_name>
      <description>intra-uterine contraceptive device</description>
      <arm_group_label>Vitamin B 1</arm_group_label>
      <arm_group_label>control</arm_group_label>
      <other_name>silverline IUD</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Females with first time use of the IUD&#xD;
  &#xD;
            -  a history of normal menstrual bleeding with duration of 3 to 7 days without spotting,&#xD;
               a menstrual cycle lasting 23 to 35 days,&#xD;
  &#xD;
            -  use of 10 to 14 sanitary pads per cycle before IUD insertion&#xD;
  &#xD;
            -  gravidity ranging between 1 and 4.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with cardiac, hepatic or renal diseases.&#xD;
  &#xD;
            -  Patients with bleeding disorders.&#xD;
  &#xD;
            -  Patients with systemic diseases.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Beni-suef University</last_name>
      <phone>082 2318605</phone>
      <phone_ext>02</phone_ext>
      <email>fom@med.bsu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 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>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>Intra-uterine Device</keyword>
    <keyword>Vitamin B 1</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamins</mesh_term>
      <mesh_term>Thiamine</mesh_term>
      <mesh_term>Vitamin B Complex</mesh_term>
      <mesh_term>Contraceptive Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05971680
  org study id: Vitamin B 1 IUD
  nct id: NCT05971680
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of
        the IUD.
  This study will be randomized controlled trial will be performed at the Obstetric and
        Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target
        Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology
        department through 3 months from the start of July 2023 till the end of November 2023.
  
        Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in
        accordance with a random table produced by an Excel program, with A being assigned to the
        intervention group and B to the control group. All women will sign a written informed consent
        prior to data collection.
  
        Each woman within the intervention group will receive a packet containing 30 pills (vitamin B
        1 or placebo), each month for three months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: the duration of menstrual bleeding.
  time frame: 3 cycles ( 3 months / one month for each cycle)
  description: days of menstruation
  arm group label: Vitamin B 1
  arm group type: Experimental
  description: VITAMIN B1 (High Potency) 500mg
  arm group label: control
  arm group type: Other
  description: patient not subjected to treatment . only follow up
  intervention type: Drug
  intervention name: VITAMIN B1 500mg
  description: VITAMIN B1 (High Potency) 500mg tab every day for 3 months
  arm group label: Vitamin B 1
  other name: VITAMIN B1 500mg @Biovea
  intervention type: Device
  intervention name: intra-uterine contraceptive device
  description: intra-uterine contraceptive device
  arm group label: Vitamin B 1
  arm group label: control
  other name: silverline IUD
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Beni-suef University
  phone: 082 2318605
  phone ext: 02
  email: fom@med.bsu.edu.eg
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Vitamins
  mesh term: Thiamine
  mesh term: Vitamin B Complex
  mesh term: Contraceptive Agents
  sharing ipd: Undecided