<?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>IRCT2012120811689N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-02-12</date_registration>
      <primary_sponsor>Vice chancellor for Research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of nigella sativa oil on rheumatoid arthritis treatment</public_title>
      <acronym></acronym>
      <scientific_title>A placebo- controlled clinical trial to determine the effects of nigella sativa oil extract on selected immune cell markers and oxidative stress in female patients with  rheumatoid arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11856</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In the present study, patients' awareness about their study group may act as a confounder variable on some of outcome measures in particular disease activity scoring. Therefore, the study will be single blinded and all the participants will receive capsules with identical shape, size, and color.</study_design>
      <phase>2</phase>
      <hc_freetext>Rheumatoid arthritis.</hc_freetext>
      <i_freetext>Intervention 1: The control group will receive two soft gel capsules containing 500 milligram paraffin as placebo every day for eight consecutive weeks. The placebo preparation process will be conducted in Barij Essence Pharmaceutical Company under established standard protocols. All the patients will receive the placebos on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews. Intervention 2: The case group will receive two soft gel capsules containing 500 milligram of nigella sativa oil extract every day for eight consecutive weeks. The extraction will be conducted by cold press method. Both the extraction and soft gel making process will be conducted in Barij Essence Pharmaceutical Company under established standard protocols. All the patients will receive the supplements on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.</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>Dr. Sorayya Kheirouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Attar Neishabouri Avenue, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>kheirouris@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sorayya Kheirouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Attar Neishabouri Avenue, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>kheirouris@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: 1) Subjects diagnosed with rheumatoid arthritis, based on American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) criteria; 2) Patients with mild to moderate rheumatoid arthritis; 3) Under treatment with disease-modifying antirheumatic drugs (Methotrexate, Hydroxychloroquine and Prednisolone less than 10 milligrams per day) and not receiving non-steroidal anti-inflammatory drugs or cytokine inhibitors; 4) Stable medication for at least 2 months prior to the interventions; 5) Have a body mass index (BMI) less than 40; 6) Willing to participate in the study; 7) Ages between 20 and 50. &#13;
Exclusion criteria: 1) Pregnant and lactating women; 2) Hormone therapy or receiving oral contraceptives; 3) Have diabetes mellitus, thyroid disorders, kidney or hepatic diseases or Cushing's syndrome; 4) Have inflammatory bowel disease or other inflammatory disorders; 5) Taking antioxidant and anti- inflammatory supplements 4 weeks prior to the interventions; 7) Being on a weight reduction diet; 7) Smoking or being exposed to cigarette smoke.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group will receive two soft gel capsules containing 500 milligram paraffin as placebo every day for eight consecutive weeks. The placebo preparation process will be conducted in Barij Essence Pharmaceutical Company under established standard protocols. All the patients will receive the placebos on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.</i_keyword>
      <i_keyword>The case group will receive two soft gel capsules containing 500 milligram of nigella sativa oil extract every day for eight consecutive weeks. The extraction will be conducted by cold press method. Both the extraction and soft gel making process will be conducted in Barij Essence Pharmaceutical Company under established standard protocols. All the patients will receive the supplements on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Catalase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>CD4+. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: flow cytometry.</prim_outcome>
      <prim_outcome>CD25+. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: flow cytometry.</prim_outcome>
      <prim_outcome>CD8+. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: flow cytometry.</prim_outcome>
      <prim_outcome>Tumor necrosis factor-alpha (TNF-α). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Interleukin 10 (IL-10). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Rheumatoid factor. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Autoanalyzer system.</prim_outcome>
      <prim_outcome>High-sensitivity C-reactive protein (hs-CRP). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Immunoturbidimetry.</prim_outcome>
      <prim_outcome>Disease Activity Score (DAS-28). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: calculation based on physical examination and serum hs-CRP.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Stethoscope and sphygmomanometer.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Stethoscope and sphygmomanometer.</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>2013-01-07</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golbad Street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
