<?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>IRCT2016040627260N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-10</date_registration>
      <primary_sponsor>Vice-chancellor for Research of Bushehr University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of autologous plasma therapy on clinical symptoms of Chronic Spontaneous Urticaria</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial on efficacy of autologous plasma therapy on clinical symptoms of Patients with Chronic Spontaneous Urticaria Compared with no treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22373</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Spontaneous Urticaria.</hc_freetext>
      <i_freetext>Patients will be divided into idiopathic and autoimmune forms of urticaria after the autologous plasma skin test. After consent to participate in the study, 5cc of brachial vein blood will be sampled first. Then we perform intradermal injection of equal measure from 0.1 cc of patient's centrifuged serum, histamine as a positive control and 0.9 % saline as a negative control at a distance of 3-5 cm from each other in the forearm and in the area that is free of rash in the past 48 hours with insulin syringes. Autologous plasma skin test is considered positive when after 30 minutes the swelling and redness diameter of serum injection area is equal or more than 1.5 mm greater than the swelling and redness of negative control injection site (normal saline). In order to treat with autologous plasma, we will take 5 ml of blood from the brachial vein using heparinized 10 ml sterile Falcon tubes from the subjects in Allergy Clinic in Bushehr Martyrs Hospital in Persian Gulf in every week for 10 weeks. Patients' plasma will be separated by centrifugation at 1000 rpm for 10 minutes and 2 cc of it will be injected deep intramuscular in gluteal or arms area alternatively..</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>Afshin Shirkani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine. Bushehr University of Medical Sciences.Moallem St. Bushehr. Iran.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3345 5388</telephone>
        <email>a.shirkani@bpums.ac.ir</email>
        <affiliation>Faculty of Medicine. Bushehr University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Shirkani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine. Bushehr University of Medical Sciences.Moallem St. Bushehr. Iran.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3345 5388</telephone>
        <email>a.shirkani@bpums.ac.ir</email>
        <affiliation>Faculty of Medicine. Bushehr University of Medical Sciences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria are urticaria for more than 2 months; Age over than 15 year old; Consent to participate in the study; Negative Prick skin test for common inhalation and food allergens and normal findings in Lab data such as CBC (Complete Blood Count), ANA (Antinuclear antibody), ESR (Erythrocyte Sedimentation Rate), LFT (Liver Function Test), U/A (Urine Analysis) and S/E (Stool Exam).&#13;
Exclusion criteria are Pregnancy; Physical urticaria; Use of corticosteroid and immunosuppressive agents during the last 6 weeks; Use of drugs other than antihistamine  and other systemic diseases.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L50.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other urticaria (Urticaria: chronic, recurrent periodic)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients will be divided into idiopathic and autoimmune forms of urticaria after the autologous plasma skin test. After consent to participate in the study, 5cc of brachial vein blood will be sampled first. Then we perform intradermal injection of equal measure from 0.1 cc of patient's centrifuged serum, histamine as a positive control and 0.9 % saline as a negative control at a distance of 3-5 cm from each other in the forearm and in the area that is free of rash in the past 48 hours with insulin syringes. Autologous plasma skin test is considered positive when after 30 minutes the swelling and redness diameter of serum injection area is equal or more than 1.5 mm greater than the swelling and redness of negative control injection site (normal saline). In order to treat with autologous plasma, we will take 5 ml of blood from the brachial vein using heparinized 10 ml sterile Falcon tubes from the subjects in Allergy Clinic in Bushehr Martyrs Hospital in Persian Gulf in every week for 10 weeks. Patients' plasma will be separated by centrifugation at 1000 rpm for 10 minutes and 2 cc of it will be injected deep intramuscular in gluteal or arms area alternatively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Qualitative clinical symptoms of urticaria. Timepoint: Before the treatment, every week during the treatment and one week after the treatment. Method of measurement: Changes in DLQI (Dermatology Life Quality Index).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quantitative clinical symptoms of urticaria. Timepoint: Before the treatment, every week during the treatment for 10 weeks and one week after the treatment. Method of measurement: Changes in TSS (Total Symptoms Score) index.</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 Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-20</approval_date>
        <contact_name>Ethics committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Salman Farsi Street, Bahmani, Medical Sciences Campus, First Floor, Bushehr, Iran Bushehr  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
