<?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>IRCT2015052322381N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-17</date_registration>
      <primary_sponsor>Neyshabour University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines &amp; highly sensitive C-reactive protein</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines and highly sensitive C-reactive protein level in the patients with Non-alcoholic fatty liver disease (A double-blind, randomized, placebo-controlled trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>43</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19311</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Two letters were prepared and written on two sheets “A” for “curcumin” and “B” for “control.” AABB, ABAB, ABBA, BBAA, BABA, BAAB, all quad blocks were possible. Then the number was selected randomly via a table of random numbers, Blinding description: To ensuring that implementation of the random allocation sequence occurs without the knowledge of which patient will receive which treatment, the entire randomization process was concealed. For this purpose, the drugs were already put in envelopes labeled a serial number from 1 to 80. No one knew the nature of the envelopes except the coordinator of the trial.</study_design>
      <phase>3</phase>
      <hc_freetext>NAFLD.</hc_freetext>
      <i_freetext>Intervention 1: Curcumin Phytosome (Meriva) with dose 250 mg/day (phospholipidated curcumin, 250 mg equivalent to 50 mg curcumin). Intervention 2: Curcumin C3 complexTM (500 mg) plus BioperineTM (5 mg, patented extract obtained from black pepper fruits (Piper nigrum) standardized minimum to 95% Piperine. Intervention 3: Control group or Placebo consumes capsules lactose with similar shape and size of intervention groups and a dose of 250 mg/day. Drug consumption is as oral during a 2-month period.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is If the request is made by a researcher, the data will be shared according to the relevant criteria.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyed Reza Mirhafez</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93186-14139</zip>
        <telephone>+98 51 4334 4011</telephone>
        <email>mirhafezr@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Seyed Reza Mirhafz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93186-14139</zip>
        <telephone>+98 51 4334 4011</telephone>
        <email>Mirhafezr@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18–65 years
The diagnosis of fatty liver using ultrasound</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Women with pregnancy/lactation
Alcoholic liver disease
Taking anti-inflammatory drugs such as Curtin
Acute or chronic liver disorders such as viral (hepatitis B and C) and autoimmune hepatitis
Metabolic liver disorders including hemochromatosis and Wilson’s disease, Budd–Chiari syndrome
Having other medical disorders such as cardiovascular diseases and cancer
Taking liver enzyme enhancement drugs
Have severe heart and lung disease
Hypothyroidism and hyperthyroidism
Alpha-1 antitrypsin deficiency
Celiac disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K75.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>nonalcoholic steatohepatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Curcumin Phytosome (Meriva) with dose 250 mg/day (phospholipidated curcumin, 250 mg equivalent to 50 mg curcumin)</i_keyword>
      <i_keyword>Curcumin C3 complexTM (500 mg) plus BioperineTM (5 mg, patented extract obtained from black pepper fruits (Piper nigrum) standardized minimum to 95% Piperine.</i_keyword>
      <i_keyword>Control group or Placebo consumes capsules lactose with similar shape and size of intervention groups and a dose of 250 mg/day. Drug consumption is as oral during a 2-month period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>NAFLD grade. Timepoint: Before intervention and two months after intervention. Method of measurement: Sonography.</prim_outcome>
      <prim_outcome>Tumor necrosis factor alpha (TNF-α). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>High-sensitivity C-reactive Protein (hs-CRP). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto-analyzer BT-2000.</prim_outcome>
      <prim_outcome>Interleukin 6 (IL-6). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Interleukin 10 (IL-10). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Monocyte Chemoattractant Protein-1 (MCP-1). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Aspartate Aminotransferase (AST). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>Alanine Aminotransferase (ALT). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>Alkaline Phosphatase (ALP). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>Fasting blood sugar (FBS). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>Triglyceride (TG). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>Total cholesterol (TC). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>High-density lipoprotein cholesterol (HDL-C). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</sec_outcome>
      <sec_outcome>Low-density lipoprotein cholesterol (HDL-C). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.</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>Neyshabour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-20</approval_date>
        <contact_name>Ethics committee of Neyshabur University Of Medical Sciences</contact_name>
        <contact_address>Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
