<?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>IRCT2014090819082N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-29</date_registration>
      <primary_sponsor>Vice chancellor for Research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of oral consumption of Nigella Sativa in the treatment of autoimmune Hypothyroidism</public_title>
      <acronym></acronym>
      <scientific_title>compare the effect of Nigella Sativa powder in the supplement group and placebo on the Serum Levels of Thyroid Hormones, Beta Transforming Growth Factor, Interlukin 23, Lipid Pattern and markers of oxidative stress in Hashimoto’s Thyroiditis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17166</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Hashimoto’s Thyroiditis.</hc_freetext>
      <i_freetext>Intervention 1: Nigella sativa group will receive 2 gram of Nigella sativa powder in the form of 1 gram packs with lunch and dinner meals for 8 weeks.The supplement will be given weekly and during the consumption possible side effects and keeping on consumption will be monitored. Intervention 2: Placebo group will receive 2 gram of starch in the form of 1-gram packs with lunch and dinner meals weekly for 8 weeks and during the consumption possible side effects and keeping on consumption will be monitored.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Significant improvements in thyroid hormones and other parameters           </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>Sirus Tajmiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan, Islamic Republic Of  Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 910 515 0752</telephone>
        <email></email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehdieh Abbasalizadeh Farhangi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>abbasalizadm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Age Range of 20-50; Suffering from Hashimoto disease with the Diagnosis of Physician based on specialized Tests; Completing Informed Consent Form. Exclusion Criteria: not signed informed consent Form; physiologic Special conditions such as pregnancy and breast-feeding; receiving supplements such as Vitamin E, C, Zinc, Folat, Cobalamin, Soy fitoestrogens in the last 3 month; suffering from any auotoimmune disease; history of thyroid operation, following any special diet</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E06.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autoimmune thyroiditis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Nigella sativa group will receive 2 gram of Nigella sativa powder in the form of 1 gram packs with lunch and dinner meals for 8 weeks.The supplement will be given weekly and during the consumption possible side effects and keeping on consumption will be monitored</i_keyword>
      <i_keyword>Placebo group will receive 2 gram of starch in the form of 1-gram packs with lunch and dinner meals weekly for 8 weeks and during the consumption possible side effects and keeping on consumption will be monitored</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum concentration ofIL-23. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum concentration ofTGF-β. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum concentration ofT4, T3، TSH،TPOAb. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum concentration ofT4, T3، TSH،TPOAb. Timepoint: At baseline and after 2 months of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Added at 2017-02-12: Serum Concentrations of MDA, GPX, SOD and TAC. Timepoint: Added at 2017-02-12: Before and after intervention. Method of measurement: Added at 2017-02-12: ELIZA.</prim_outcome>
      <prim_outcome>Added at 2017-02-12: Serum TAC. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELIZA.</prim_outcome>
      <prim_outcome>Added at 2017-02-12: Serum CAT. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELIZA.</prim_outcome>
      <prim_outcome>Added at 2017-02-12: Serum GPX. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELIZA.</prim_outcome>
      <prim_outcome>Added at 2017-02-12: Serum SOD. Timepoint: Added at 2017-02-12: At baseline and after 2 months of intervention. Method of measurement: Added at 2017-02-12: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical Activity. Timepoint: At baseline and after 2 months of intervention. Method of measurement: Physical Activity Questionare.</sec_outcome>
      <sec_outcome>Receiving Energy and Macronutrients. Timepoint: Before The first month termination and after the eight week. Method of measurement: 24-hour memorial questionare.</sec_outcome>
      <sec_outcome>BMI. Timepoint: At baseline and after 2 months of intervention. Method of measurement: Weight divided by Height Square.</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, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-04</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golbad Street, Tabriz, East Azerbayjan, Iran Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
