<?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>IRCT201707283860N33</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-17</date_registration>
      <primary_sponsor>Vice Chancellor for research of International Branch of Shahid  Beheshti University of Medical Scien</primary_sponsor>
      <public_title>Clinical trial Study of the Effect of Ginger Plant Capsules on Reducing the Pain in Women with Postpartum  Pain</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial Study of the Effect of Ginger Plant Capsules on Reducing the Pain in Women with Postpartum Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3997</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study was a three-blind study in which the researcher, samples and counselor are not known aboat the type of capsules. The capsules are placed in a coded container and randomly given to the participators.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Postpartum pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mefenamic acid at the dose of 500 mg (two 250mg capsules) plus Zintoma, Produced by Gol Dara Company, at the dose of 500 mg (two 250mg capsules) are prescribed two hours after delivery and then one Mefenamic acid and Zintoma are prescribed every 8 hours until 24 hours. Intervention 2: Control group: Mefenamic acid at the dose of 500 mg (two 250mg capsules) plus placebo (containing Chickpea Flour Produced by Gol Daru similar to Zintoma in Dose and shape) , at the dose of 500 mg (two 250mg capsules) are prescribed two hours after delivery and then one Mefenamic acid and one placebo are prescribed every 8 hours until 24 hours.</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>Giti Ozgoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niyayesh H.,valiasr st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00982188202512</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>g.ozgoli@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Giti Ozgoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niayesh H.,valiasr st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>g.ozgoli@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Iranian with reading and writing skills; Delivery by vaginal method; Pregnancy age of 38 weeks and more; The baby's weight more than 2500 grams; Having a living and normal baby; Mothers without  previous cesarean or surgery history; lasting 2 hours after delivery; childbirth without the help of instrument (Vacuum and Forceps) or pressure on the uterus;absence of drug addiction; having no history of allergies to ginger and herbal medicine; mother with  complains of after pain; absence of uses of  medications and analgesia (epidural anesthesia, Spinal anesthesia, Entonox and pethidine)during labour; the mother is not affected by chronic disease, such as diabetes and hypertension; spontaneous existance of placenta and membrane.&#13;
Exclusion Criteria: Maternal complications such as increased postpartum hemorrhage, fever and blood pressure over 140/90; requiring surgery and anesthetics.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postpartum care and examination</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: Mefenamic acid at the dose of 500 mg (two 250mg capsules) plus Zintoma, Produced by Gol Dara Company, at the dose of 500 mg (two 250mg capsules) are prescribed two hours after delivery and then one Mefenamic acid and Zintoma are prescribed every 8 hours until 24 hours.</i_keyword>
      <i_keyword>Control group: Mefenamic acid at the dose of 500 mg (two 250mg capsules) plus placebo (containing Chickpea Flour Produced by Gol Daru similar to Zintoma in Dose and shape) , at the dose of 500 mg (two 250mg capsules) are prescribed two hours after delivery and then one Mefenamic acid and one placebo are prescribed every 8 hours until 24 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before the intervention, half,one  and two hours after intervention, then every 8 hours. Method of measurement: Numerical Measurement Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number of additional painkiller intake. Timepoint: 2 hours after delivery and then every 8 hours for 24 hours. 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>Vice Chancellor for research of International Branch of Shahid  Beheshti University of Medical Scien</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-01</approval_date>
        <contact_name>Ethic committee of Pharmacy and Midwifery Medical schools, Shahid Beheshti University of Medical Sci</contact_name>
        <contact_address>Niyayesh Highway.,Valiasr st Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
