<?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>IRCT20170929036477N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-10</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of curcumin and vitamin D s on headache symptoms and inflammation in patients with migraine</public_title>
      <acronym></acronym>
      <scientific_title>The effect of concurrent curcumin and vitamin D supplementation on headache symptoms and calcitonin gene-related peptide level (CGRP) in patients with migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57843</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible subject  be selected with convenience sampling and be randomly assigned into 2 groups of 25 subjects as treatment and control  with block sizes of  3 and 6 with proportion 1:1. A person from research team not involved in the recruitment and assigning participants generate allocation sequence using web site of www.Randomization.com, Blinding description: After explaining the purpose of the study, all participants and investigators are blinded to random allocation. Participants in vitamin D group receive vitamin D 1000 IU supplement and curcumin capsules while control group take placebo with the same size and color as vitamin D(Oral paraffin)   soft gels and curcumin.</study_design>
      <phase>3</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": migraine patients intake curcumin supplement in the form of 500 mg capsules from Karen Company, one per day with routine treatment (200 mg sodium valproate tablets from Sajad Darou 2/day and two 20 mg propranolol tablets from Tolid Darou) and a soft oral vitamin D capsule with a dose of 2000 international units produce by Zahravi Company daily for 60 days. Intervention 2: "Control group": migraine patients intake placebo of curcumin and vitamin D supplement one per day with routine treatment (two 200 mg sodium valproate tablets and two 20 mg propranolol tablets) for 60 days.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Siavash Fazelian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street</address>
        <city>Shahrekod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813833435</zip>
        <telephone>+98 912 839 0366</telephone>
        <email>Siavashfazelian@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siavash Fazelian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Street</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۳۸۳۳۴۳۵</zip>
        <telephone>+98 912 839 0366</telephone>
        <email>Siavashfazelian@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate with the plan
Diagnosis of migraine by a neurologist based on ICHD-3 criteria.
Age 20 to 50 years.
No chronic diseases (liver, kidney, cardiovascular disease, secondary headache or other types of primary headache except migraine)
Absence during pregnancy and lactation
No taking dietary supplements or medication (nutritional supplements, multivitamin mineral and W3 supplements or anti-migraine medications (valproate, amitriptyline, etc.), anti-inflammatory and anti-depressant pills, Aspirin and NSAIDs, contraceptives in the last three months
Failure to follow a specific diet or exercise program during the last three months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>alcohol and smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": migraine patients intake curcumin supplement in the form of 500 mg capsules from Karen Company, one per day with routine treatment (200 mg sodium valproate tablets from Sajad Darou 2/day and two 20 mg propranolol tablets from Tolid Darou) and a soft oral vitamin D capsule with a dose of 2000 international units produce by Zahravi Company daily for 60 days.</i_keyword>
      <i_keyword>"Control group": migraine patients intake placebo of curcumin and vitamin D supplement one per day with routine treatment (two 200 mg sodium valproate tablets and two 20 mg propranolol tablets) for 60 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of  migraine. Timepoint: Before the intervention and at the end of the study. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Migraine frequency. Timepoint: Before the intervention and at the end of the study. Method of measurement: Question / Number of attacks per month.</prim_outcome>
      <prim_outcome>Duration of migraine headache. Timepoint: Before the intervention and at the end of the study. Method of measurement: Question / Number of attacks per month.</prim_outcome>
      <prim_outcome>The degree of disability caused by migraines. Timepoint: Before the intervention and at the end of the study. Method of measurement: Headache Impact Test Questionnaire.</prim_outcome>
      <prim_outcome>Calcitonin gene-related peptide. Timepoint: Before the intervention and at the end of the study. Method of measurement: blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-11</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Science</contact_name>
        <contact_address>Kashani Street Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
