<?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>IRCT20180110038302N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-29</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ginger on headache and shivering after spinal anesthesia in patients with cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of ginger on prevention of headache and shivering   after spinal anesthesia in patients with cesarean section referred to Kamali hospital in Karaj, 2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29124</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Firstly, a list of women from Cesarean section was prepared weekly. Then they were contacted with each one and the purpose and method of the study were explained. A written consent was obtained from women eligible to enter the study and each person was given an ID. Then, a simple random allocation  was performed based on table of random numbers. Beginning,  direction of numbers were determinate from top to bottom of table of random numbers. Based on the direction of the top-down table, the even numbers were selected for the intervention group and the odd numbers for the control group. These numbers were recorded on a sheet and allocated to the intervention and control groups. This process were continued until the sample size (170) was completed. Thus, two groups, each with 85 participants were formed.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Post Anesthesia Shivering(PAS), Post dural puncture headache(PDPH). Condition 2: Complications of spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: "In the intervention group"  24 hours before cesarean section, ginger capsule was prescribed 250 mg every 8 hours. After cesarean section, prescriptions for capsules continued before headache. In the event of headache, intervention was discontinued and routine headache treatment was used. Intervention 2: "Control  group": No intervention  in control group.</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>Mansoureh Yazdkhshti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karaj-Baghestan- Southern Common Blvd.-Alborz Nursing-Midwifery Faculty</address>
        <city>karj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1829346253</zip>
        <telephone>+98 26 3430 4499</telephone>
        <email>Mansoyazd@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Banafsheh Mushak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karaj - Shahid Beheshti Avenue - Kamali Hospital Street</address>
        <city>karj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1829346253</zip>
        <telephone>+98 26 3222 2021</telephone>
        <email>mashakbanafsheh@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:1- Age of 20 to 40 years 2. pregnancy (37-42 weeks) and single Pregnant women who candidate for elective cesarean section; ASA class 1,2  .3 - Receiving written consent from patients. 4. No history of psychiatric problems. 5. Absence of hypothyroidism. 6. No meningitis at the time of study. 7. No migraine. 8.  No seizure or headache. 9. Start a headache within first 72 hours after spinal anesthesia. 10-  No Pre-eclampsia or eclampsia.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: 1-unwillingness for participating in the study   at each stage 2-  cesarean section that lasts more than an hour 3- Fevered patients or unstable vital signs 4.history of psychotropic or opium drugs consumption 5.  alcohol or drug abuse 6. Drug sensitivity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"In the intervention group"  24 hours before cesarean section, ginger capsule was prescribed 250 mg every 8 hours. After cesarean section, prescriptions for capsules continued before headache. In the event of headache, intervention was discontinued and routine headache treatment was used.</i_keyword>
      <i_keyword>"Control  group": No intervention  in control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache   Intensity. Timepoint: From 24 hours before cesarean section every 8 hours and continue after cesarean section until headache. Method of measurement: Visual analog scale(VAS) ( 0 -10)  was used to measure the severity of headache.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shivering intensity. Timepoint: 1, 3, 12 and 72 hours after cesarean. Method of measurement: Crossover-Mahajan criterion for measuring shivering (from 0 to 4).</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-20</approval_date>
        <contact_name>Alborz University of Medical Science</contact_name>
        <contact_address>No.1, Eshteraki Blvd, Baghestan street, school of nursing And midwifery, karaj, Iran karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
