<?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>IRCT201207109472N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-19</date_registration>
      <primary_sponsor>Vice-chancellor for Research, Tehran University of Medical Sciences, Vice chancellor for Research, I</primary_sponsor>
      <public_title>The effect of Ginger powder consumption on inflammation  and Immunity  in Rheumatoid arthritis disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Ginger consumption on the some immunity and inflammatory mediators in adult with active Rheumatoid arthritis  referingto Shariaty Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10051</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>1</phase>
      <hc_freetext>adult active Rheumatoid arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Patients that refer to hospital shariatti have interval criteria and will receive Ginger voluntarily.  Patients in case group will receive 1500 mg of powdered Ginger daily (by two 750 mg capsules) for 3 months ne 750 mg capsule before lunch and one before dinner for 3 months. Intervention 2: Control groups: Patients that refer to hospital shariatti have interval criteria and will receive starch or flour voluntarily.  Patients in Control group will receive 1500 mg of wheat flour daily (by two 750 mg capsules) one 750 mg capsule before lunch and one before dinner 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naheed Aryaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of public health, Iran University of Medical Sciences, Hammat Bld.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8670 4755</telephone>
        <email>aryaeian@razi.tums.ac.ir</email>
        <affiliation>Nutrition faculty, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naheed Aryaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of nutrition, School of public of health, Iran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4755</telephone>
        <email>n-aryaeian@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: person with RA diseases  as ACR criteria, having  RA from 2 years ago; age between 18-69 years; not being pregnant or lactated; not smoking and drink alcohol;  haven’t eaten multivitamin or antioxidants supplements from 3 month ago; don't eat lowering blood pressure; don't eat anti pregnancy drugs,&#13;
exclusion criteria: Changes in diet or physical activity every day; taking less than 80% of supplements given to patients at baseline(the compliance lower than %80); consumption of contraceptives, multivitamins and antioxidant supplements; renal , hepatic , thyroid, parathyroid diseases, cancer, heart diseases</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</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>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Patients that refer to hospital shariatti have interval criteria and will receive Ginger voluntarily.  Patients in case group will receive 1500 mg of powdered Ginger daily (by two 750 mg capsules) for 3 months ne 750 mg capsule before lunch and one before dinner for 3 months.</i_keyword>
      <i_keyword>Control groups: Patients that refer to hospital shariatti have interval criteria and will receive starch or flour voluntarily.  Patients in Control group will receive 1500 mg of wheat flour daily (by two 750 mg capsules) one 750 mg capsule before lunch and one before dinner for 3 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HsCRP. Timepoint: Before and after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>IL17. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>TNFa. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>IL10. Timepoint: Before and after treatment. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>IL2. Timepoint: Before and after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>DAS28. Timepoint: Before and after study. Method of measurement: using ESR,CRP and number of joints with inflammation.</prim_outcome>
      <prim_outcome>IL4. Timepoint: Before and after treatment. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>ESR. Timepoint: Before and after the study. Method of measurement: Westergern method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BMI. Timepoint: Before and after intervention. Method of measurement: weight(kg)/height(m*2).</sec_outcome>
      <sec_outcome>Nsaids intake. Timepoint: Before and after intervention. Method of measurement: 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>Vice-chancellor for Research, Tehran University of Medical Sciences, Vice chancellor for Research, I</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-02-04</approval_date>
        <contact_name>Tehran university of medical sciences</contact_name>
        <contact_address>Tehran university of medical sciences,Research deputy Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
