<?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>IRCT20200406046967N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-10</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Colchicine in treatment of chronic urticaria</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of colchicine on the antithyroid antibody titer in chronic urticaria patient.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46991</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is based on a  Random number table. In this study, table numbers are read from above and to the right.
Couples' numbers are for the first group (intervention) and individual numbers are for the second group (control), Blinding description: Patients know that they are participating in the study and have entered the study consciously and with prior written consent, but do not know exactly which group they are in.
he main researchers of the study are unaware of the type of medication used for each patient and how the patients are assigned to the groups and which group each patient is in.
Data collection and follow-up officials are unaware of the type of medication used for each patient and how the patients are assigned to the groups and which group each patient is in.</study_design>
      <phase>3</phase>
      <hc_freetext>Positive Autoantibody Chronic Urticaria.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  "The first intervention group of Fexofenadine tablets 120 mg once daily for 3 months from Saha Pharmaceuticals, Doxepin tablets 10 mg once daily for 3 months from Razak Pharmaceuticals and Colchicine tablets 1 mg once daily for 3 months from Modava Pharmaceuticals". Intervention 2: Intervention group: "The second intervention group of Fexofenadine tablets 120 mg once daily for 3 months from Saha Pharmaceuticals, Doxepin tablets 10 mg once daily for 3 months from Razak Pharmaceuticals" ;.</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:
All data can be shared after people have not been identified.

When:
Starting the access period 3 months after the publication of the results

To whom:
It will be available for researchers worker in academic and scientific institutions.

Conditions:
they can provide jobs, university and reason of using data and articles.

Where to obtain:
Email adress

How to obtain:
2 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masroor Babaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, Niki 2 building, Ansar 1 Ave, besat Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184684189</zip>
        <telephone>+98 71 3649 9543</telephone>
        <email>masroor.babaeian@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masroor Babaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor., Niki 2 building ., 1 Ansar Ave ., besat Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184684189</zip>
        <telephone>+98 71 3649 9543</telephone>
        <email>Masroor.babaeian@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic urticaria in the age range of 20 to 70 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant and lactating females
Patients with  Physical Urticaria and Vasculitis Urticaria
Patients with Colchicine-induced drug side effects</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L50.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Idiopathic urticaria</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:  "The first intervention group of Fexofenadine tablets 120 mg once daily for 3 months from Saha Pharmaceuticals, Doxepin tablets 10 mg once daily for 3 months from Razak Pharmaceuticals and Colchicine tablets 1 mg once daily for 3 months from Modava Pharmaceuticals"</i_keyword>
      <i_keyword>Intervention group: "The second intervention group of Fexofenadine tablets 120 mg once daily for 3 months from Saha Pharmaceuticals, Doxepin tablets 10 mg once daily for 3 months from Razak Pharmaceuticals" ;</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Percentage of people with chronic urticaria who have autoimmune thyroiditis". Timepoint: "Measurement of thyroid autoantibodies at the beginning of the study (before the intervention) and 3 months after taking colchicine". Method of measurement: "Peripheral blood sample".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>" The urticaria score in the Urticaria Activity Score 7 questionnaire". Timepoint: " Comparison of the average total score of the Urticaria Activity Score 7 questionnaire in the study groups at the beginning of the study and 3 months after taking colchicine". Method of measurement: " Urticaria Activity Score 7 questionnaire".</sec_outcome>
      <sec_outcome>"The urticaria score in the  Chronic  Urticaria  Quality  of  Life questionnaire". Timepoint: Comparison of the average total score of the Chronic Urticaria Quality of Life questionnaire in the study groups at the beginning of the study and 3 months after taking colchicine". Method of measurement: "Chronic Urticaria Quality of Life 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-08</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>3rd floor., Niki 2 building., Ansar Ave., besat Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
