<?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>IRCT20171225038058N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-09</date_registration>
      <primary_sponsor>Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>Compare the effect of Matricaria CHamomile capsule  and Achillea  Millefolium capsule on menestural pain.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study on the effect of Matricaria CHamomile capsule and Achillea  Millefolium capsule  on primary dysmenorrhea intensity in university students.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28417</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Initialy one month before taking CHamomile capsule and Achillea Millefolium capsule, demographic and menstrual characteristic questionnaire and the visual Analog Scale will be given to eligible university students and asked them to complete it, in the first three days of menstrual cycle before taking medications.Then envelopes containing 250 mg Matricaria CHamomile capsule or capsule containing150 mg hydro alcoholic extract of Achillea Millefolium made by Kermanshah College of Pharmacy and named as code A or code B is distributed among participants by colleague researcher. Each code represents the existence of one of a variety of capsules inside the envelope and the researcher does not know which of the participants will use the envelope A or the envelope B. Only the pharmacist knows the nature of envelopes contain capsules. researcher, her colleague and participants are unaware of of the type of capsules, Blinding description: By sealing a sealed envelope; individuals may randomly build a Kermanshah Pharmacy School in the capsule group of 250 mg of Matricaria CHamomile,  Kermanshah Pharmacy Department or in the group of Achillea Millefolium  hydro-alcoholic capsules of Kermanshah, Color, size and aroma are quite similar and will be provided by the research collaborator. Apart from the pharmacist, the investigator or the participants will not know the nature of the medications.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: Oral capsule 150 mg of Achillea Millefolium  (constructed at Kermanshah Pharmacy Faculty) is takan every 8 hours after meal  during the first 3 days of menstruation in the first and second cycles of their menstruation. Intervention 2: Control group: Oral capsule 250 mg of Matricaria CHamomile  (constructed at Kermanshah Pharmacy Faculty) is taken every 8 hours after meal during the first 3 days of menstruation in their first and second cycle of menstruation.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Radtar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran  Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۶۱۷۷۱۵۱۷۵</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>Shivaradfar53@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Laila Hashemi nasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۶۱۷۷۱۵۱۷۵</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>hasheminasab.l.2014@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be single
Their menstruation start at the age of 11 to 17
Regular menstrual cycles every 21-35 days
A score of 4 to 10 for menstrual pain according to the visual analogue scale
Volunteered to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have Abnormal bleeding
Have history of any Herbal allergy
Have Epilepsy
Have Coagulation disorder
Have Allergic asthma
Have Digestive diseases
Have Liver disease
Have Renal disease
Have Ovarian cyst
Have Myoma
Have pelvic tumor
Have Endometriosis
Consume Benzodiazepines
Consume Barbiturates
Consume Narcotics
ConsumeTricyclic antidepressants
Consume Anticoagulants
Consume Theophylline
Consume Steroid hormones drugs
Oral contraceptive pills in the last three months were consumed
Consume Alcohol
Known Mental illness
Have Pelvic inflammatory disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: Oral capsule 150 mg of Achillea Millefolium  (constructed at Kermanshah Pharmacy Faculty) is takan every 8 hours after meal  during the first 3 days of menstruation in the first and second cycles of their menstruation.</i_keyword>
      <i_keyword>Control group: Oral capsule 250 mg of Matricaria CHamomile  (constructed at Kermanshah Pharmacy Faculty) is taken every 8 hours after meal during the first 3 days of menstruation in their first and second cycle of menstruation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary dysmenorrhea intensity. Timepoint: Before intevention، 1, 2, 4, 6 hours after intervention. Method of measurement: Visulal Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of menstrual bleeding. Timepoint: Before intervention and at the end of the third day of the first cycle and the second cycle of menstruation, after taking the Matricaria CHamomile capsule and Achillea Millefolium capsule. Method of measurement: Pictorial blood assessment chart.</sec_outcome>
      <sec_outcome>Side effects of taking the Matricaria CHamomile capsule and Achillea Millefolium capsule. Timepoint: At the end of the third day of the first cycle and the second cycle of menstruation, after taking the Matricaria CHamomile capsule and Achillea Millefolium capsule. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The number of menstruation days. Timepoint: Before intervention and at the end of the second menstrual cycle after intervention. Method of measurement: The questionnaire based on the number of menstrual days.</sec_outcome>
      <sec_outcome>Side effects of taking the Matricaria CHamomile capsule and Achillea Millefolium capsule. Timepoint: At the end of the second menstrual cycle after intervention. 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>Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-19</approval_date>
        <contact_name>Ethics committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences; Pasdaran Blov sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
