<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20160308026962N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-03</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of vitamin D and vitamin E on  Intensity and Duration of Dysmenorrhea</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Vitamin D and Vitamin E on Ameliorating Intensity and Duration of Dysmenorrhea in Iranian Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized clinical trial, samples will be randomly selected and randomly selected based on a table of random numbers into 4 equal groups of 25, including 3 experimental groups and a control group. In this study, assignment sequencing and preparation Supplemental and placebo packages in similar packages will be done by a person not involved in sampling and data collection. He did not know about the study groups, Blinding description: This study is an RCT (randomized clinical trial) and will be performed on adouble-blind side . In this way, neither the subjects nor the person who will analyze the data will know which drug group and which treatment group received the treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>The Effect of Vitamin D and Vitamin E on Ameliorating Intensity and Duration of Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Group receiving 50,000 mg of vitamin D gelatin capsule available from a pharmacy for three months to evaluate the duration and severity of dysmenorrhea. Intervention 2: Intervention group:Group receiving vitamin E400 gelatin capsule, made by Dana Company in Iran for three months to evaluate the duration and severity of dysmenorrhea. Intervention 3: Intervention group:Group receiving vitamin D and vitamin E gelatin capsules for three months to evaluate the duration and severity of dysmenorrhea. Intervention 4: Control group: Group receiving placebo for three months to evaluate the duration and severity of dysmenorrhea.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data related to the participants' file can be accessed by correspondence by e-mail.

When:
Start the access period 6 months after publication of results

To whom:
Researchers working in academic and scientific institutions

Conditions:
The use of data for scientific research on topics related to the objectives of the study is unrestricted.

Where to obtain:
To the person in charge of scientific response using their email

How to obtain:
Objectives and proposals should be sent by e-mail upon request by scientific authorities

Comments:
In order to empower other researchers in the field of obstetrics and gynecology, we are ready to work with respected researchers.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Behroozi Lak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 7707</telephone>
        <email>t.behrooz2@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Behroozi Lak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3224 0166</telephone>
        <email>t.behrooz2@yahoo.com</email>
        <affiliation>Educational and Treatment Kowsar Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being within the age group of 18-50 years
Were no present history of gynecologic or psychological diseases, no urogenital disorders
No usage of herbal remedies
No history of coagulation disordersand
No history of iregular menstrual cycles
No history of pelvic or abdominal surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Individuals with a history of specific illness
Individuals with a history of forced drug use
Individuals with a history of symptoms such as burning, itching, discharge,
Individuals with a history of irregular periods</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Group receiving 50,000 mg of vitamin D gelatin capsule available from a pharmacy for three months to evaluate the duration and severity of dysmenorrhea</i_keyword>
      <i_keyword>Intervention group:Group receiving vitamin E400 gelatin capsule, made by Dana Company in Iran for three months to evaluate the duration and severity of dysmenorrhea</i_keyword>
      <i_keyword>Intervention group:Group receiving vitamin D and vitamin E gelatin capsules for three months to evaluate the duration and severity of dysmenorrhea</i_keyword>
      <i_keyword>Control group: Group receiving placebo for three months to evaluate the duration and severity of dysmenorrhea</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain duration. Timepoint: Once before giving the desired treatments and placebo and once after a month and finally two months of continuous use of drugs and placebo. Method of measurement: Cox Menstrual Symptom Scale Questionnaires.</prim_outcome>
      <prim_outcome>Severity of the pain. Timepoint: Once before giving the desired treatments and placebo and once after a month and finally two months of continuous use of drug and placebo. Method of measurement: Visual Analog Scale(VAS) Questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time to start pain. Timepoint: Monthly. Method of measurement: Questionnaire before and after menstruation.</sec_outcome>
      <sec_outcome>Menstrual status. Timepoint: Monthly. Method of measurement: Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-25</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciens</contact_name>
        <contact_address>Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia university of medical sciens Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
