<?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>IRCT20230202057310N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-27</date_registration>
      <primary_sponsor>Muhammad  Institute  of  Medical  and  Allied  Sciences,  Multan,  Pakistan.</primary_sponsor>
      <public_title>Rosuvastatin and 10-week resistance band exercises for obese individuals of Multan</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of rosuvastatin and 10-week resistance band exercises for obese individuals of Multan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>380</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator, Blinding description: Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1: Participants in the drug intervention group will receive e.g., Rosuvastatin 5mg administered orally once daily. This medication has been selected based on its established efficacy in lowering LDL cholesterol and improving overall lipid profiles. Intervention 2: Intervention group: Participants in the exercise intervention group will undergo a structured resistance training program, tailored to individual fitness levels and conducted under the supervision of a certified exercise trainer.Exercise Protocol: The exercise regimen will include a 5-minute warm-up, 30 minutes of resistance training (including chest press, seated row, shoulder press, biceps curl, squats, deadlift, wood chopper, Russian twists), followed by a 5-minute cool-down. Training sessions will be held three times a week for 10 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>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 N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maliha Khalid Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Multan</address>
        <city>MULTAN</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 312 6827130</telephone>
        <email>malihatareen1997@gmail.com</email>
        <affiliation>Muhammad  Institute  of  Medical  and  Allied  Sciences,  Multan,  Pakistan.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Old shuja Abad road Multan</address>
        <city>MULTAN</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 333 6120602</telephone>
        <email>imran.ahmad@mnsuam.edu.pk</email>
        <affiliation>Muhammad Nawaz Sharif University of Agriculture Multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults aged 18-65 years   •
Diagnosed with dyslipidemia, defined as elevated levels of total cholesterol (≥200 mg/dL)
Able and willing to adhere to either drug therapy or a structured exercise program
LDL cholesterol (≥130 mg/dL)
Triglycerides (≥150 mg/dL)
ow HDL cholesterol (&lt;40 mg/dL for men, &lt;50 mg/dL for women)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of cardiovascular diseases (e.g., myocardial infarction, angina)
Uncontrolled hypertension (≥160/100 mmHg)
Conditions contraindicating exercise (e.g., musculoskeletal disorders)
Recent history of smoking or current tobacco use
Current use of lipid-lowering drugs or recent participation in a structured exercise program
Pregnant or lactating women</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1: Participants in the drug intervention group will receive e.g., Rosuvastatin 5mg administered orally once daily. This medication has been selected based on its established efficacy in lowering LDL cholesterol and improving overall lipid profiles</i_keyword>
      <i_keyword>Intervention group: Participants in the exercise intervention group will undergo a structured resistance training program, tailored to individual fitness levels and conducted under the supervision of a certified exercise trainer.Exercise Protocol: The exercise regimen will include a 5-minute warm-up, 30 minutes of resistance training (including chest press, seated row, shoulder press, biceps curl, squats, deadlift, wood chopper, Russian twists), followed by a 5-minute cool-down. Training sessions will be held three times a week for 10 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profile parameters (total cholesterol, LDL, HDL, and triglycerides). Timepoint: 10 weeks. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: 10 weeks. Method of measurement: Calculated from weight and height (measured using a digital scale and stadiometer).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: 10 weeks. Method of measurement: Measured using a calibrated sphygmomanometer after a 5-minute rest in a seated position.</sec_outcome>
      <sec_outcome>Waist-to-Hip Ratio, Hip to knee ration and Hip circumference. Timepoint: 10 weeks. Method of measurement: Assessed using a flexible measuring tape.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: 10 weeks. Method of measurement: SF-36.</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>Muhammad  Institute  of  Medical  and  Allied  Sciences,  Multan,  Pakistan.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-07</approval_date>
        <contact_name>The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences</contact_name>
        <contact_address>Bosan Road Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
