<?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>IRCT20191222045853N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-06</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effects of nano-curcumin on obstructive pulmonary disease patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of nano-curcumin supplementation on ventilatory capacity, polmonary function indices and serum interleukin-6 of patients with stage 3 (severe) and 4 (very severe) chronic obstructive pulmonary disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44453</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the block randomization method. We have two case and control groups (C and T) that will have 6 models using 4 blocks (TTCC, TCTC, TCCT, CCTT, CTCT, CTTC). Subjects randomly will be assigned to case and control groups, Blinding description: Using coding on supplements.</study_design>
      <phase>3</phase>
      <hc_freetext>chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: nano-curcumin supplement, one capsule daily, each capsule contains 80 mg of curcumin in the form of nanomicelles, for 12 weeks, consumed with food, produced by Sina company. Intervention 2: Control group: Placebo, one capsule daily, each capsule consists of polysorbate, propylene glycol and distilled water for 12 weeks, consumed with food, produced by Sina company.</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 Release will be made but its exact schedule has not been determined yet. In future updates, information will be entered.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasoul Zarrin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orjhans Street, Resalat Blvd</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>571478334</zip>
        <telephone>+98 44 3222 9059</telephone>
        <email>mahdieh.zareie72@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Zareie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition department, school of medical sciences, Urmia University of Medical Sciences, Nazlou Rd.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>571478334</zip>
        <telephone>+98 44 3278 0803</telephone>
        <email>mahdieh.zareie72@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• Adult age range (18-65 years).
Smokers who have been smoking for at least 10 years.
Confirmation of chronic obstructive pulmonary disease according to GOLD criteria.
The patient has stages 3 and 4 of chronic pulmonary obstruction.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with gallstones
Infectious diseases
Gastrointestinal problems such as malabsorption
Other chronic diseases (such as cancer, kidney disease, diabetes, etc.).
Long-term use of corticosteroid drugs and compounds, ie, more than 10 days of corticosteroid use per year.
Use of any anticoagulant drugs such as heparin, aspirin, clopidogrel, dipyridamole, warfarin and ticlopidine.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: nano-curcumin supplement, one capsule daily, each capsule contains 80 mg of curcumin in the form of nanomicelles, for 12 weeks, consumed with food, produced by Sina company.</i_keyword>
      <i_keyword>Control group: Placebo, one capsule daily, each capsule consists of polysorbate, propylene glycol and distilled water for 12 weeks, consumed with food, produced by Sina company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interleukin-6. Timepoint: beginning and end of supplementation. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Spirometry. Timepoint: beginning and end of supplementation. Method of measurement: Spirometere.</prim_outcome>
      <prim_outcome>Anthropometric measurements. Timepoint: beginning and end of supplementation. Method of measurement: Bioelectric impedance device.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: beginning and end of supplementation. Method of measurement: sphygmomanometer.</prim_outcome>
      <prim_outcome>Dietary intake. Timepoint: beginning and end of supplementation. Method of measurement: Food record form.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: beginning and end of supplementation. Method of measurement: international physical activity questionnaire.</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>Vice chancellor for research, Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-07</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Orjhans Street, Resalat Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
