<?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>IRCT201509182889N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-09</date_registration>
      <primary_sponsor>Isfahan Research Department of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of auriculotherapy and vitamin B6 on the symptoms of premenstrual syndrome</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparing the effect of auriculotherapy and vitamin B6 on the symptoms of premenstrul syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2763</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Sealed  envelope method.</study_design>
      <phase>3</phase>
      <hc_freetext>premenstrual  syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: the auriculotherapy will be executed in 10 weekly sessions during 2 menstruation cycles (except for the 7 days of menstrual bleeding). Each session  will be lasted about 20 minutes and will be conducted by the researcher at the dorm in a private place that will be considered for this matter. At each session Shenmen, zero, endocrine, ovary, womb, adrenal, kidney, external genitalia, liver, brain and brainstem points will be stimulated. At the end of each session herbal seeds will be placed on specified points and will be remained for at least 3 days; seeds  will be pressured by the participant for a whole minute every hour except for the time of sleep. Phone calls will be made for reminding. Intervention 2: Intervantion group 2: They will take Vitamin B6 (40 mg) (made by Iran Hormone Company), daily from one week before starting of menstrual bleeding. This group will continue the consumption of B6 during the two months.</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>sharareh koleini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Science, Hezar jereb street, Shiraz Gate</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199939438</zip>
        <telephone>+98 31 3792 2936</telephone>
        <email>sharareh_Koleini@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboube Valiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ms</address>
        <city>Isfahan of university of medical sciences</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199939438</zip>
        <telephone>+98 31 3792 2936</telephone>
        <email>valiani@nm.mui.ac.ir</email>
        <affiliation>Isfahan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18 to 35 year old; having regular menstruation cycles with equal intervals (22 to 35 days); having 5 signs of pms in  last 2 months; normal BMI ; not having a history of psychological or chronic physical diseases and depression; Not having a history of using anti-depressant; sedatives and hormonal drugs and also drugs that have interactions with vitamin B6 and not having any kind of mass, infection or scar on the external ear .&#13;
&#13;
 Exclusion criteria: Occurrence of any undesirable incidence or death; not presenting all the auriculotherapy sessions correctly and completely (more than 2 consecutive absences);not pressuring the seeds in the auriculotherapy group and not completing the table of symptoms’ severity recordings would cause the participants to be excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>premenstrual tention syndrome</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>Intervention group 1: the auriculotherapy will be executed in 10 weekly sessions during 2 menstruation cycles (except for the 7 days of menstrual bleeding). Each session  will be lasted about 20 minutes and will be conducted by the researcher at the dorm in a private place that will be considered for this matter. At each session Shenmen, zero, endocrine, ovary, womb, adrenal, kidney, external genitalia, liver, brain and brainstem points will be stimulated. At the end of each session herbal seeds will be placed on specified points and will be remained for at least 3 days; seeds  will be pressured by the participant for a whole minute every hour except for the time of sleep. Phone calls will be made for reminding.</i_keyword>
      <i_keyword>Intervantion group 2: They will take Vitamin B6 (40 mg) (made by Iran Hormone Company), daily from one week before starting of menstrual bleeding. This group will continue the consumption of B6 during the two months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Premenstrual syndrome(edema, low back pain,low abdominal pain,mastalgia,..). Timepoint: Before of  intervention, 1,2,month after intervention. Method of measurement: DSM-IV questionnair.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General health-Depression-Anxiety. Timepoint: preintervention -1 and 2month after intervention. Method of measurement: GHQ(28) and Beck questionairs.</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>Isfahan Research Department of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-22</approval_date>
        <contact_name>Isfahan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Isfahan university of Medical sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
