<?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>IRCT20110531006660N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-12</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Omega3 in Treatment of Chronic Urticaria</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Omega3 Function in the Treatment of Chronic Urticarial, with Clinical Evaluation and Adaptive Innate Immune Response in the double-blind Model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7086</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this Study, Simple Randomization Method is Used with the Numerical Table, Blinding description: In this Study, Research Fellow, Specialist Evaluating the Clinical Conditions and the Delivery of the Drug is not Aware of how the Drug is Administered, and the Drugs will be Delivered to the Patient in the Numbered Package to the Patient and the Packet Number will be Recorded in the list of Patients. As well as those who Receive the drug, are not Aware of the Placebo, and are being Evaluated.</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic urticaria.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: Omega3 Containing 180 mg of EPA  and 120 mg of DHA, one Daily for 3 Months. Intervention 2: Intervention group: This Group will Receive the Placebo-Omega-3 drug. Intervention 3: Control group: Omega-3 Placebo, one Daily for 3 Months.</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:
In this Study, all the Information on the main Outcome that Includes the Patient's clinical Recovery, as well as the Side Effects Including the Evaluation of serum proteins, Including cytokines, are Shared after taking the Drug

When:
The time to Start Accessing Data will be one Month after the Data is Printed

To whom:
The Data in this Study is Available to Researchers in Academic and Scientific Institutions as well as in Non-Related Fields.

Conditions:
The Data is Available after Printing and the Specified time Period and is used to Improve the Scientific Level

Where to obtain:
Dr.Javad Ghaffari
Email: Ghafari@mazumse.ac.ir
Contact Number: 09113510359

How to obtain:
This Data will be Available to the Applicant one Month after Printing

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Javad Ghaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research and Technology Dept, Building No. 2, Teacher's Square, Teacher's Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48157-33971</zip>
        <telephone>+1 133257230</telephone>
        <email>ghafari@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Javad Ghaffari. Dr Alireza Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research and Technology Dept, Building No. 2, Teacher's Square, Teacher's Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48157-33971</zip>
        <telephone>+1 133257230</telephone>
        <email>ghafari@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chronic Idiopathic Urticaria
Age between 10 and 40 Years Old
Receiving Antihistamines
Patient Approval
Completion of Treatment for at least 30 Days</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Concomitant illness; whether allergic or non-allergic ;  Use of non-Antihistamine Medication
Age Less than 10 and above 40
Acute Hives
Physical Urticaria
Hypersensitivity or Antihistamine
Anaphylaxis
Pregnant Women</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>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: Omega3 Containing 180 mg of EPA  and 120 mg of DHA, one Daily for 3 Months.</i_keyword>
      <i_keyword>Intervention group: This Group will Receive the Placebo-Omega-3 drug</i_keyword>
      <i_keyword>Control group: Omega-3 Placebo, one Daily for 3 Months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical resolution of urticaria. Timepoint: before and after treatment. Method of measurement: UAS7.</prim_outcome>
      <prim_outcome>Thymic Stromal Lymphopoietin (TSLP). Timepoint: Before intervention and 3 months after intervention. Method of measurement: Reverse Transcription Polymerase Chain Reaction (RT-PCR) and  Enzyme-Linked Immunosorbent Assay (ELIZA).</prim_outcome>
      <prim_outcome>Interferon Gama. Timepoint: Before intervention and 3 months after intervention. Method of measurement: RT-PCR و ELIZA.</prim_outcome>
      <prim_outcome>Interleukine4 (IL4). Timepoint: Before intervention and 3 months after intervention. Method of measurement: RT-PCR و ELIZA.</prim_outcome>
      <prim_outcome>IL35. Timepoint: Before intervention and 3 months after intervention. Method of measurement: RT-PCR و ELIZA.</prim_outcome>
      <prim_outcome>IL32. Timepoint: Before intervention and 3 months after intervention. Method of measurement: RT-PCR و ELIZA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-31</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Sari, Khazar Square, Farah Abad Road, Km 18, Complex of the Great Prophet Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
