<?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>IRCT20181014041334N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-02</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of three therapeutic drug regimen for the treatment of a withdrawal headache</public_title>
      <acronym></acronym>
      <scientific_title>Evaluate the comparative  effectiveness of three therapeutic drug regimen for the treatment of a withdrawal  headache in patients with medication overuse headache, referring to the neurology clinic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34628</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For each group, there will be 10 envelopes for men and 10 envelopes for women containing the group number (20 envelopes for each group). The Clinic Clerk will randomly pick up an envelope from one group for delivery to the eligible patient. For women, this should be the same. At the same time, one Female person within a group should be entered in parallel with one male one, until finally, 10 men and 10 women will be enrolled in the study within each group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Medication Overuse Headache (MOH).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: celecoxib (100 mg, Cap, Iran, Tehran, Daru Pars, celecoxib 100 mg three times daily for the first five days, 100 mg twice daily (five days later) and 100 mg once a day (five The next day). Intervention 2: Intervention group: Prednisolone Tablets (Aburaihan Pharmaceutical, Iran, Tehran, .Co, 50 mg, 5 mg) 75 mg (three first days) 50 mg (three days later) 30 mg (three The next day (25 mg three days later) and 10 mg (the last 3 days). Intervention 3: Intervention group: celecoxib 100 mg three times daily + 75 mg prednisolone for the first 4 days, celecoxib 100 mg twice daily + 50 mg prednisolone for the second 4 days, celecoxib  100 mg once daily + 25 mg prednisolone for 4 days, 100 mg once daily + 10 mg prednisolone for 3 last day.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Moh  data

When:
year

To whom:
scientific valid researchers

Conditions:
with authority

Where to obtain:
Dr chehregani email

How to obtain:
should be requested via email or valid scientific  web site such as research gate

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Afshin Chehreghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ershad</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>afshin.chehregani@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Arash Mosarrezaii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ershad</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>mosarrezaii.a@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 18 to50 year
Patients with headache more than 15 days per month
A history of regular use of one or more symptomatic treatment medications over a period of more than a month, including ergotamine, tryptan, combination of analgesic drugs (simple and combination), tryptones, ergotamine and narcotics (more than 10 days per month for more than 3 months), or analgesic drugs Simple such as acetaminophen or NSAIDs (10 days per month in regular three months)
A headache that progresses or gets worse in the course of drug abuse
lack of mental psychological illness
no pregnancy
No previous history or disease has been detected
not having platelet disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>lack of referral for the follow up
Arbitrary discontinuation of patient medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other headache syndromes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: celecoxib (100 mg, Cap, Iran, Tehran, Daru Pars, celecoxib 100 mg three times daily for the first five days, 100 mg twice daily (five days later) and 100 mg once a day (five The next day)</i_keyword>
      <i_keyword>Intervention group: Prednisolone Tablets (Aburaihan Pharmaceutical, Iran, Tehran, .Co, 50 mg, 5 mg) 75 mg (three first days) 50 mg (three days later) 30 mg (three The next day (25 mg three days later) and 10 mg (the last 3 days)</i_keyword>
      <i_keyword>Intervention group: celecoxib 100 mg three times daily + 75 mg prednisolone for the first 4 days, celecoxib 100 mg twice daily + 50 mg prednisolone for the second 4 days, celecoxib  100 mg once daily + 25 mg prednisolone for 4 days, 100 mg once daily + 10 mg prednisolone for 3 last day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache severity. Timepoint: 15 days. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Headache duration. Timepoint: daily. Method of measurement: headache duration (days).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug dependence reduction. Timepoint: 15 days. Method of measurement: Used Drug Dosage.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-30</approval_date>
        <contact_name>Urmia Medical Science University Ethical committee</contact_name>
        <contact_address>Resalat Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
