<?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>IRCT20200614047766N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-30</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effect of curcumin in Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Curcumin on Oxidant , Antioxidant factors ,Liver ,Kidney tests  serum , Clinical signs and symptoms of MultipleSclerosis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48888</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with divided randomization with block sizes of 4 and 6 blocks will be divided into two groups of cases (MS patients who will receive curcumin in 48 people) and Dardonema (MS patients who will receive placebo in 48 people). In this way, we paste 96 randomly selected codes on 96 cans of capsules that are similar in color, shape and size, and after pouring the curcumin capsule and placebo capsule according to the codes in the cans, we put all the cans. Pour into a bag, Blinding description: According to the codes we have, Razak's 370 mg curcumin capsules will initially be given twice daily to the CASE group and the placebo-containing placebo capsule to the placebo group by the doctor's secretary (who has no knowledge of the type of capsules or what group of patients are in which). In this way, the doctor, the researcher and the patient have no knowledge of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: MS patients who take Corkomine oral capsule for 3 months at a dose of 370 mg, take one a day at the beginning of the study and then take it twice a day. It has high antioxidant properties. Intervention 2: Control group: MS patients who receive placebo 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>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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Goodarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9881, 30 Shams Alley, Football Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3815899881</zip>
        <telephone>+98 86 3276 3858</telephone>
        <email>kiyangolmohamadi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Rezaei Ashtiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.3345, Mir Ahmad Doctors Building,Adalat Alley, Shahid Beheshti St, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3223 9388</telephone>
        <email>farahaniheidar@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study subjects must have RRMS type Ms disease
They are 18 to 50 years old and EDSS (disease incapacity severity) must be less than 4
Patients who have been diagnosed with MS for at least one year
Patients who do not have a specific digestive problem (gastric and duodenal ulcers, irritable bowel syndrome, indigestion)
Not sensitive to curcumin
They do not receive zinc or selenium supplements
Antioxidant corticosteroids, such as vitamin E-A-D, have not been used for at least the past two weeks.
They are not pregnant
Don't be a breastfeeding woman
They do not have special liver or kidney problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of willingness of the patient to continue cooperation
patients with mental disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: MS patients who take Corkomine oral capsule for 3 months at a dose of 370 mg, take one a day at the beginning of the study and then take it twice a day. It has high antioxidant properties.</i_keyword>
      <i_keyword>Control group: MS patients who receive placebo for 3 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total oxidative status. Timepoint: Measurement of total oxidative status at the beginning of the study (before the start of the intervention) and 3 months after the start of use of curcumin capsules. Method of measurement: Total Oxidative Status Measurement Kit.</prim_outcome>
      <prim_outcome>Malone Dialdehyde. Timepoint: Measurement of malondialdehyde at the beginning of the study (before the intervention) and 3 months after the start of use of curcumin capsules. Method of measurement: Malon dialdehyde Measurement Kit.</prim_outcome>
      <prim_outcome>آب اکسیژنه. Timepoint: Measurement of oxygenated water at the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules. Method of measurement: Oxygenated water measurement kit.</prim_outcome>
      <prim_outcome>Super Oxide Dismutase. Timepoint: Measurement of dismutase superoxide at the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules. Method of measurement: Dysmotase Super Oxide Measurement Kit.</prim_outcome>
      <prim_outcome>Glutathione Revival. Timepoint: Measurement of glutathione reductase at the beginning of the study (before the start of the intervention) and 3 months after the start of the use of curcumin capsules. Method of measurement: Glutathione Revitalization Measurement Kit.</prim_outcome>
      <prim_outcome>Aspartate amino transferase. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin. Method of measurement: Aspartate aminotransferase assay kit.</prim_outcome>
      <prim_outcome>Alanin amino transferase. Timepoint: The beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin. Method of measurement: Alanine Amino Transfer Measurement Kit.</prim_outcome>
      <prim_outcome>Blood creatinine. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin. Method of measurement: Creatine measuring kit.</prim_outcome>
      <prim_outcome>Nitrogen in the blood urea. Timepoint: At the beginning of the study and 3 months after taking curcumin. Method of measurement: Blood urea nitrogen measurement kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Expanded Disability Status Scale. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Fatigue Severity Scale. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Gait disorder. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the start of use of curcumin capsules. Method of measurement: 25 foot test.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-08</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Payambar Azam University Complex, Basij Square, Sardasht St Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
