<?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>IRCT20251104067880N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-14</date_registration>
      <primary_sponsor>Alzahra University, Tehran</primary_sponsor>
      <public_title>Investigating the effect of high-intensity functional training combined with Terminalia chebula supplementation in women with metabolic syndrome.</public_title>
      <acronym>TC. HIFT. Mets</acronym>
      <scientific_title>The Effect of High-Intensity Functional Training Combined with Terminalia chebula Supplementation on Nitric Oxide, C-Reactive Protein, Insulin Resistance, and Cardiometabolic Risk in Women with Metabolic Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Basic scienece, Other design features: The current study includes exercise and herbal supplementation to improve metabolic health in people with metabolic syndrome, Randomization description: Simple randomization. According to the call for volunteers to participate in the study (women with metabolic syndrome), blood tests and the desired factors were measured. We placed the people in 4 groups of 15 people without regard to specific criteria and with completely equal chances. (That is, the people in the exercise or supplemental exercise or mock or control group are no different from each other.), Blinding description: those responsible for data collection, such as the nurse responsible for blood tests, do not know who is in the control, exercise, supplement, and supplement and exercise groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Women with metabolic syndrome.</hc_freetext>
      <i_freetext>Exercise group. Supplement group. Exercise and supplement group. Control group. Interventions are applied to the first three groups for 8 weeks. 3 training sessions per week and 500 mg supplement capsules are taken twice a day for 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 No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deh Vanak Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1993891176</zip>
        <telephone>+98 71 4434 0448</telephone>
        <email>fateehesmaeili7762@gmail.com</email>
        <affiliation>Alzahra University, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deh Vanak Street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1993891176</zip>
        <telephone>+98 71 4434 0448</telephone>
        <email>fatemehesmaeili7762@gmail.com</email>
        <affiliation>Alzahra University, Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria for the present study were waist circumference greater than 88 cm, blood triglyceride level greater than 150 mg/dL, HDL level less than 50 mg/dL, systolic blood pressure greater than 130 mmHg or diastolic blood pressure greater than 85 mmHg, and blood glucose level greater than 100 mg/dL. Failure to attend more than three training sessions, unwillingness to continue participating in the study, failure to take supplements regularly, and physical injury were exclusion criteria.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Subjects will not be included in the study if they have the following conditions: smoking and alcohol consumption, history of or suffering from any heart, lung, kidney, liver or neurological disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Exercise group. Supplement group. Exercise and supplement group. Control group. Interventions are applied to the first three groups for 8 weeks. 3 training sessions per week and 500 mg supplement capsules are taken twice a day for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nitric oxide, C-reactive protein, insulin resistance, and cardiometabolic risk are not balanced and optimal. Timepoint: Measurements of all factors considered are measured on two days (the first day for blood factors and the second day for physical performance) before and after 8 weeks. Method of measurement: Nitric oxide, C-reactive protein, and insulin resistance are measured with blood tests, and cardiometabolic risk is measured using blood pressure measurements, waist circumference to height, and the Cooper test to measure aerobic capacity.</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>do not have</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-04</approval_date>
        <contact_name>کمیته تخصصی اخلاق در پژوهش های زیست پزشکی</contact_name>
        <contact_address>Alzahra University  Deh Vanek St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
