<?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>IRCT2016060728313N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-12</date_registration>
      <primary_sponsor>Islamic Azad University Of Ardabil Branch</primary_sponsor>
      <public_title>The effect of Fennel on treatment Dysmenorrhea</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Fennel and Gelofen on the severity of primary Menstrual pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22997</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Medicine and registration form (for  before and after the use of medicine) for the first cycle will be distributed and information on how to take the medicine is presented to everybody in Experimental Group. The Experimental Group will use Fennel Drop in three first day of Menstrual cycle, 3-5 drops in tea or water 3 times a day (every 8 hours) in 3 continuous series of Menstrual cycles. At the end of each cycle by fellow researchers collected clinical status and drug registration forms and will distributed new forms and medicine. The samples will be followed-up after three consecutive cycles. Verbal Multidimensional Scoring System to determine the severity of Menstrual pain is used to determine the presence or absence of symptoms associated with pain will be determined as well as through a Questionnaire. Intervention 2: Medicine and registration form (for  before and after the use of medicine) for the first cycle will be distributed and information on how to take the medicine is presented to everybody in Control Group. The Control Group also use Gelofen Capsules at a dose of 400 milligram 4 times per day with meals or a glass of water in the first 3 days of the Menstrual cycle. At the end of each cycle by fellow researchers collected clinical status and drug registration forms and will distributed new forms and medicine. The samples will be followed-up after three consecutive cycles. Verbal Multidimensional Scoring System to determine the severity of Menstrual pain is used to determine the presence or absence of symptoms associated with pain will be determined as well as through a Questionnaire.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roya Motavalli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Ardabil, Iran</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615731567</zip>
        <telephone>+98 45 3372 8025</telephone>
        <email>mrmotavalli@yahoo.com</email>
        <affiliation>Islamic Azad University Of Ardabil Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Parvin Nakhostinroohy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Arbabil, Iran</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615731567</zip>
        <telephone>+98 45 3372 8025</telephone>
        <email>mrmotavalli@yahoo.com</email>
        <affiliation>Islamic Azad University Of Ardabil Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The incidence of primary dysmenorrhea grade 2 and 3 according to verbal multidimensional scoring criteria.&#13;
&#13;
Exclusion criteria: Use of birth control pills and herbal medicines; As well as painkillers and other relaxation techniques or acupressure to relieve dysmenorrhea; Having of renal; hepatic; respiratory; and blood diseases; Having of sensitivity to NSAIDs and fennel.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary Dysmenorrhoea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Medicine and registration form (for  before and after the use of medicine) for the first cycle will be distributed and information on how to take the medicine is presented to everybody in Experimental Group. The Experimental Group will use Fennel Drop in three first day of Menstrual cycle, 3-5 drops in tea or water 3 times a day (every 8 hours) in 3 continuous series of Menstrual cycles. At the end of each cycle by fellow researchers collected clinical status and drug registration forms and will distributed new forms and medicine. The samples will be followed-up after three consecutive cycles. Verbal Multidimensional Scoring System to determine the severity of Menstrual pain is used to determine the presence or absence of symptoms associated with pain will be determined as well as through a Questionnaire.</i_keyword>
      <i_keyword>Medicine and registration form (for  before and after the use of medicine) for the first cycle will be distributed and information on how to take the medicine is presented to everybody in Control Group. The Control Group also use Gelofen Capsules at a dose of 400 milligram 4 times per day with meals or a glass of water in the first 3 days of the Menstrual cycle. At the end of each cycle by fellow researchers collected clinical status and drug registration forms and will distributed new forms and medicine. The samples will be followed-up after three consecutive cycles. Verbal Multidimensional Scoring System to determine the severity of Menstrual pain is used to determine the presence or absence of symptoms associated with pain will be determined as well as through a Questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of Menstrual pain. Timepoint: Three months after the begining of interaction. Method of measurement: Verbal Multidimensional Scoring Criteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side Effects. Timepoint: Three months after the begining of interaction. 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>Islamic Azad University Of Ardabil Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-09</approval_date>
        <contact_name>Islamic Azad University Of Ardabil Branch</contact_name>
        <contact_address>Basij Square, Ardabil, Iran Ardabil  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
