<?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>IRCT138808272731N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-02-16</date_registration>
      <primary_sponsor>Tarbait Modares University</primary_sponsor>
      <public_title>The evaluation of effect of acupressure on primary dysmenorrheal</public_title>
      <acronym></acronym>
      <scientific_title>The evaluation of effect of acupressure on primary dysmenorrheal</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2576</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Inclusion criteria: age 18-21 years, having regular menstrual cycles (duration of  3-8 days and interval of 21-35 days). presence of moderate to severe pain i.e. a score of 4 or more on a wrong-Baker faces pain scale, presence of symptoms of liver channel,  presence of fix or sharp pain in lower abdomen for 1-2 day prior to onset of menstruation, distension feel in abdomen and breast, presence of dark-colored menstruation with clotting, irritability or depression and sometimes sleeplessness prior to onset of menstruation, tongue with red-colored seed, worsening  the pain with pressure on abdominal), no prior history of gynecological disease or abdominal or pelvic surgery, no pain during menstrual cycle or menstruation duration, 2 hours after meal&#13;
Exclusion criteria: history of mental stress in last 6 month especially having moderate to severe level of depression (score of 19 or more in beck-21 inventory), taking analgesics during 4 hours before intervention, menstruation cycle lower than 25 days or more than 35 days, use of tobacco products, or alcohol, presence of verbal, audible, mental problems, heart disease, kidney disease, diabetes mellitus, asthma, hyperthyroid or hypothyroid, or respiratory disease, presence of scar or inflammatory disease in acupoint.</study_design>
      <phase>N/A</phase>
      <hc_freetext>primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: In the experiment group, acupressure done on liv3 point located two thumb-widths behind the skin-margin between the first (big) and second toes for 3-7 days before the onset of menstruation for 20 minutes and follow up for 4 menstruation cycles. Intervention 2: In the control group, acupressure done on placebo point located two thumb-widths behind the skin-margin between the first (big) and second toes for 3-7 days before the onset of menstruation for 20 minutes and follow up for 4 menstruation cycles.</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>Fatemeh Bazarganipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gisha bridge, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 2188220209396</telephone>
        <email>fatimabazargani@yahoo.comf.bazarganipour@gmail.combazarganipour@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoor Lamyian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gisha bridge, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3809</telephone>
        <email>lamyianm@yahoo.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 18-21 years, having regular menstrual cycles (duration of  3-8 days and interval of 21-35 days). presence of moderate to severe pain i.e. a score of 4 or more on a wrong-Baker faces pain scale, presence of symptoms of liver channel,  presence of fix or sharp pain in lower abdomen for 1-2 day prior to onset of menstruation, distension feel in abdomen and breast, presence of dark-colored menstruation with clotting, irritability or depression and sometimes sleeplessness prior to onset of menstruation, tongue with red-colored seed, worsening  the pain with pressure on abdominal), no prior history of gynecological disease or abdominal or pelvic surgery, no pain during menstrual cycle or menstruation duration, 2 hours after meal&#13;
Exclusion criteria: history of mental stress in last 6 month especially having moderate to severe level of depression (score of 19 or more in beck-21 inventory), taking analgesics during 4 hours before intervention, menstruation cycle lower than 25 days or more than 35 days, use of tobacco products, or alcohol, presence of verbal, audible, mental problems, heart disease, kidney disease, diabetes mellitus, asthma, hyperthyroid or hypothyroid, or respiratory disease, presence of scar or inflammatory disease in acupoint.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>21 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>Pain and other conditions associated with female genital organs and menstrual cycle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experiment group, acupressure done on liv3 point located two thumb-widths behind the skin-margin between the first (big) and second toes for 3-7 days before the onset of menstruation for 20 minutes and follow up for 4 menstruation cycles</i_keyword>
      <i_keyword>In the control group, acupressure done on placebo point located two thumb-widths behind the skin-margin between the first (big) and second toes for 3-7 days before the onset of menstruation for 20 minutes and follow up for 4 menstruation cycles</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver channel symptoms. Timepoint: first and fourth cycles. Method of measurement: liver channel symptoms questionnare-interview to patient.</prim_outcome>
      <prim_outcome>Severity of dysmenorrhea. Timepoint: first and fourth cycles. Method of measurement: multidimensional scoring system -interview with patient.</prim_outcome>
      <prim_outcome>Pain severity. Timepoint: monthly. Method of measurement: wrong-Baker faces pain scale-interview to patient.</prim_outcome>
      <prim_outcome>Pain duration. Timepoint: monthly. Method of measurement: questionnare-interview to patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tarbait Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Tarbiat Modares Unovercity</contact_name>
        <contact_address>Tehran, Gisha bridge Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
