<?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>IRCT138812222602N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-03-13</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of lipoic acid on inflammation and antioxidant factors in multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of lipoic acid on antioxidant factors, Th1/Th2 balance and clinical signs in multiple sclerosis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2373</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>muiltiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: lipoic acid supplement (1200mg/day) for 90 days. Intervention 2: control group: 2 capsuls including dietary fiber.</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. Shahriar Eghtesadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health, Alvand Ave, Arjanteen Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>egtesadi@iums.ac.ir, egtesadi@yahoo.com</email>
        <affiliation>School of Health, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shahriar Eghtesadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health, Alvand Ave, Arjanteen Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8877 9118</telephone>
        <email>egtesadi@iums.ac.ir, eghtesadi@yahoo.com</email>
        <affiliation>School of Health, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 18-51 years, able to provide informed consent and diagnosed with relapsing remitting MS.   Exclusion criteria: MS exacerbation during the study, systemically administered corticosteroids during the study , pregnant or breast-feeding , other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus and other autoimmune disease) that might increase the risk of subject experiencing adverse events. Consumption of vitamin, mineral and antioxidant supplement 30 days before study entry, Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study and compliance less than 70%.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>51 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>lipoic acid supplement (1200mg/day) for 90 days</i_keyword>
      <i_keyword>control group: 2 capsuls including dietary fiber</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease serum lipoic acid concentration. Timepoint: 12 week. Method of measurement: HPLC.</prim_outcome>
      <prim_outcome>Decrease serum TNF-a concentration. Timepoint: 12 week. Method of measurement: labratory kit.</prim_outcome>
      <prim_outcome>Decrease serum MDA concentration. Timepoint: 12 week. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Increase SOD. Timepoint: 12 week. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Increase glutathione peroxidase. Timepoint: 12 week. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Decrease serum ADA concentration. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Decrease serum INF-y concentration. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Increase TGF-B. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Increase IL-6. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Increase IL-4. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Decrease MMP-9. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Decrease VCAM-1. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>Decrease ICAM-1. Timepoint: 12 week. Method of measurement: ELYSA.</prim_outcome>
      <prim_outcome>TAC. Timepoint: 12 week. Method of measurement: colorimetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease EDSS. Timepoint: 12 week. Method of measurement: observation.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-07-19</approval_date>
        <contact_name>School of Health, Iran University of Medical Sciences</contact_name>
        <contact_address>Alvand Ave, Arjanteen Square Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
