<?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>IRCT20210413050958N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-31</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of curcumin on cardiopulmonary efficacy</public_title>
      <acronym></acronym>
      <scientific_title>The effects of curcumin on the cardiopulmonary efficacy in subjects with central obesity: A Randomized, Double-Blind, Placebo-Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64521</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The statistician generates a random allocation sequence using the block randomization method. So that blocks with size 4 and 2 of the combination of letters A and B (ABBA, ABAB, AABB, BAAB, BBAA, BABA), (AB and BA) are selected to the required number using a table of random numbers and individuals are assigned to groups according to the created sequence. Subjects are divided into one of two intervention/control groups using a table of random numbers, so that who enrolled the trial can select a sealed envelope with random allocation sequence to the intervention or control group. An expert outside the research team blinds the drugs. The executive team register the subjects and assign them to the intervention. All volunteers, the executive team, and the statistical analyst will be blinded by the interventions, Blinding description: The random allocation sequence is made using the table of random numbers. Sequentially numbered sealed envelopes are used to implement the random allocation sequence which opened by a person not involved in the project. The participants, care providers and statistician are blinded after assignment to intervention. So that, the powders bottles are coded by a non-researcher person and remain confidential until data analysis. Moreover, In addition, placebo powder is similar to supplement powder in shape, weight and color.</study_design>
      <phase>2</phase>
      <hc_freetext>central obesity.</hc_freetext>
      <i_freetext>Intervention 1: The treatment group (n= 25) including subjects with central obesity based on NCEP-ATP III. Curcumin (C3 complex) at a dose of 500 mg/day plus 5 mg piperine is taken orally over 8 weeks purchased from Sami Labs LTD (Bangalore, India) in the intervention group. Intervention 2: The control group includes subjects with central obesity based on NCEP-ATP III. Placebo at a dose of 500 milligram per day containing 5 mg of piperine too that purchased from Sami Labs LTD (Bangalore, India) and are the same shape and color with curcumin that is received orally by control group over 8 weeks.</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 Raw data will be shared upon a reasonable request from the corresponding author.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Saberi-Karimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaem Hospital, Ahmadabad Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99199-91766</zip>
        <telephone>+98 51 3882 3260</telephone>
        <email>saberikm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Saberi-Karimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaem Hospital, Ahmadabad Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99199-91766</zip>
        <telephone>+98 51 3882 3260</telephone>
        <email>saberikm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Signed informed consent form
Aged 18-65 years old
Subjects with central obesity based on NCEP-ATP III guidelines</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of systemic diseases
History of cardiac ischemia
Pregnancy
Breastfeeding
Hepatic failure
Biliary obstruction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The treatment group (n= 25) including subjects with central obesity based on NCEP-ATP III. Curcumin (C3 complex) at a dose of 500 mg/day plus 5 mg piperine is taken orally over 8 weeks purchased from Sami Labs LTD (Bangalore, India) in the intervention group.</i_keyword>
      <i_keyword>The control group includes subjects with central obesity based on NCEP-ATP III. Placebo at a dose of 500 milligram per day containing 5 mg of piperine too that purchased from Sami Labs LTD (Bangalore, India) and are the same shape and color with curcumin that is received orally by control group over 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximal oxygen consumption (V̇O2max). Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ratio of minute ventilation to carbon dioxide output (VE/V CO2). Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Dead-space ventilation (Vd/Vt). Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Alveolar-arterial oxygen pressure gradient [P(A-a)O2]. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: sphygmomanometer.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>Lipid profile (Total cholestrol, Triglyceride, High density lipoprotein, Low density lipoprotein). Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: Auto analyzer.</sec_outcome>
      <sec_outcome>Anaerobic threshold. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Peak heart rate. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Heart rate reserve. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Peak work. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Ventilator reserve. Timepoint: Before the intervention and 8 weeks after taking supplement or placebo. Method of measurement: cardiopulmonary exercise testing (CPET).</sec_outcome>
      <sec_outcome>Respiratory frequency. Timepoint: cardiopulmonary exercise testing (CPET). Method of measurement: cardiopulmonary exercise testing (CPET).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-24</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghoreishi buildings, Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
