<?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>IRCT2017080135444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-06</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of nanocurcumin and ubiquinone in migraine treatment</public_title>
      <acronym></acronym>
      <scientific_title>The combined effects of nanocurcumin and ubiquinone supplementation on serum levels of homocysteine, calcitonin gene-related peptide, oxidative stress index, gene expression and activity of some antioxidant enzymes in migraine patients: Randomized double blind placebo controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26783</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Migraine without aura.</hc_freetext>
      <i_freetext>Patients will be divided into four groups, according to stratified randomization method: 1.The group receiving ubiquinone (sauna medicine in Parseh, Iran) (100 mg three times daily) and nanocorcomin (Sina Kurkamin, Iran) (80 mg per day). 2.Nano-curcumin supplement and ubiquinone placebo (Minoo Co., Iran). 3.ubiquinone Supplement and Curcumin Placebo (Minoo Co., Iran). 4.The control group consisted of patients receiving ubiquinone placebo and curcumin placebo for two 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>Mohammad Prohan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Hojjat Doust Alley, Naderi ave, Keshavarz Blvd, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>prohan-m@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Prohan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Hojjat Doust Alley, Naderi ave, Keshavarz Blvd, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>prohan-m@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 20 to 45 years old; Patients with episodic migraine; Migraine Diagnosis by International Headache Society Criteria as Applied by a Neurologist; No nutritional supplement or professional sports activities four weeks before intervention; People who are willing to cooperate voluntarily. Exclusion criteria: Kidney disease; liver disease; pancreatitis; diabetes; cancer; thyroid disorders and inflammatory diseases based on medical history; Malnutrition (body mass index less than 18.5) and obesity (body mass index greater than 30); Vitamin supplementation during the three months before intervention; Pregnancy; Alcohol consumption over the past six months; smoking; Patients with history of cardiovascular disease; Taking anti-inflammatory drugs or supplements such as ubiquinone and curcumin; Allergic reaction to the ubiquinone and/or Curcumin supplement; Lack of patient collaboration; Any significant changes in diet and routine life.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine without aura [common migraine]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients will be divided into four groups, according to stratified randomization method: 1.The group receiving ubiquinone (sauna medicine in Parseh, Iran) (100 mg three times daily) and nanocorcomin (Sina Kurkamin, Iran) (80 mg per day). 2.Nano-curcumin supplement and ubiquinone placebo (Minoo Co., Iran). 3.ubiquinone Supplement and Curcumin Placebo (Minoo Co., Iran). 4.The control group consisted of patients receiving ubiquinone placebo and curcumin placebo for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of headache attacks. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Questionnaires to assess disease progression.</prim_outcome>
      <prim_outcome>Duration of the headache. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Questionnaires to assess disease progression.</prim_outcome>
      <prim_outcome>Headache severity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Questionnaires to assess disease progression.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of calcitonin gene-related peptide. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using appropriate laboratory methods for each variable.</sec_outcome>
      <sec_outcome>Serum levels of homocysteine. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using appropriate laboratory methods for each variable.</sec_outcome>
      <sec_outcome>Oxidative stress profile. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using appropriate laboratory methods for each variable.</sec_outcome>
      <sec_outcome>Activity of antioxidant enzymes catalase, superoxide dismutase, glutathione peroxidase. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using appropriate laboratory methods for each variable.</sec_outcome>
      <sec_outcome>Gene expression of anti-oxidant enzymes catalase, superoxide dismutase, glutathione peroxidase in peripheral blood mononuclear cells. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using appropriate laboratory methods for each variable.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-01</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No. 44, Hojjat Doust Alley, Naderi ave, Keshavarz Blvd, Tehran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
