<?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>IRCT20221213056809N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-26</date_registration>
      <primary_sponsor>Ilam University</primary_sponsor>
      <public_title>The effect of progressive aerobic exercises along with curcumin supplementation on physiological indicators in obese girls recovered from corona</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of progressive aerobic exercises with curcumin supplementation on inflammatory indices, lipid indices and cardio-pulmonary function in obese girls recovered from corona</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70306</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be examined by simple random selection in four groups. In relation to randomization, the names of 40 subjects are written on special cards and placed in a bag, and the cards are selected one after the other. After choosing each card from the bag, the card was placed in the bag again, Blinding description: Supplementation will be distributed based on the randomization results announced by the laboratory supervisor among the intervention group and placebo in the control group by the laboratory officials, and the researchers will not know about the randomization results and the type of packaging they have delivered. subjects. The researcher only needs to prepare the necessary supplement for the intervention and deliver it to the laboratory supervisor.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: experimental group 1 (progressive aerobic exercise + curcumin supplement, 10 people), eight weeks of aerobic activity with a frequency of three times a week for one hour and consumption of two to three capsules of curcumin according to the individual's body mass index. Intervention 2: Intervention group: experimental group 2 (progressive aerobic exercise + placebo 10 people), eight weeks of aerobic activity with a frequency of three times a week for one hour and placebo consumption of capsules containing starch. Intervention 3: Intervention group: experimental group 3 (curcumin supplement 10 people), taking two to three capsules of curcumin according to the body mass index of the person and not prescribing aerobic exercise. Intervention 4: Control group: experimental group 4 (control/no intervention 10 people), no intervention group without supplement prescription and exercise.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
If you need more information about the research, the required information will be shared through an official email to the person in charge.

When:
6 months

To whom:
Professors, students

Conditions:
If you need more information about the research

Where to obtain:
Through an official email to the responsible person

How to obtain:
3 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Kazemizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah Province, Kermanshah, Zakariya Razi Blvd,</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۷۱۴۴۱۴۹۷۱</zip>
        <telephone>+98 83 4522 1718</telephone>
        <email>vahid13k17@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nabi Shamsaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ilam Province, Ilam, Research Blvd</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>693917111</zip>
        <telephone>+98 84 5924 1000</telephone>
        <email>na.shamsaei@yahoo.cim</email>
        <affiliation>Ilam University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 25-35
Recovered from corona disease
8 months of recovery after contracting the corona disease
Body mass index greater than 25
Being female</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of chronic diseases such as cardiovascular diseases, diabetes, various cancers, kidney, and digestive disorders
Smoking history
Having any type of injury or problem that prevents participation in physical activities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>UO8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Personal history of COVID-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: experimental group 1 (progressive aerobic exercise + curcumin supplement, 10 people), eight weeks of aerobic activity with a frequency of three times a week for one hour and consumption of two to three capsules of curcumin according to the individual's body mass index.</i_keyword>
      <i_keyword>Intervention group: experimental group 2 (progressive aerobic exercise + placebo 10 people), eight weeks of aerobic activity with a frequency of three times a week for one hour and placebo consumption of capsules containing starch</i_keyword>
      <i_keyword>Intervention group: experimental group 3 (curcumin supplement 10 people), taking two to three capsules of curcumin according to the body mass index of the person and not prescribing aerobic exercise</i_keyword>
      <i_keyword>Control group: experimental group 4 (control/no intervention 10 people), no intervention group without supplement prescription and exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammatory indices (IL-6, TNF-a). Timepoint: In the pre-test stage and after 8 weeks in the post-test stage, after 12 hours of fasting, the subjects will be present at the Kermanshah Central Laboratory (Reference) in the presence of a nursing expert from the Kermanshah Health Center. Method of measurement: Inflammatory indices (IL-6, TNF-a) will be measured using the ELISA kit of Carmania Parsgene Company, made in Iran, by the sandwich method.</prim_outcome>
      <prim_outcome>Lipid indices (TG, TC, LDL, HDL). Timepoint: In the pre-test stage and after 8 weeks in the post-test stage, after 12 hours of fasting, the subjects will be present at the Kermanshah Central Laboratory (Reference) in the presence of a nursing expert from the Kermanshah Health Center. Method of measurement: Lipid profile will be measured using bionic kit and enzymatic method.</prim_outcome>
      <prim_outcome>Cardiorespiratory function. Timepoint: In the pre-test stage and after 8 weeks in the post-test stage, after 12 hours of fasting, the subjects will be present at the Kermanshah Central Laboratory (Reference) in the presence of a nursing expert from the Kermanshah Health Center. Method of measurement: In relation to pulmonary function evaluation, the spirometer test will be used using the spirometer (Spirolab New) brand (MIR) made in Italy to record the pulmonary function index.</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>Ilam University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-24</approval_date>
        <contact_name>Ethics Committee of Ilam University</contact_name>
        <contact_address>Ilam Province, Ilam, Research Blvd Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
