<?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>IRCT20220307054211N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-15</date_registration>
      <primary_sponsor>Aburaihan pharmaceutical co.</primary_sponsor>
      <public_title>Comparison of the hormonal responses to Levothyroxin made by Aburaihan company with Levothyroxine made by Merck company</public_title>
      <acronym></acronym>
      <scientific_title>Non-inferiority Randomized Controlled Clinical Trial of the hormonal responses to Levothyroxin made by Aburaihan company and Levothyroxine made by Merck company</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The drug will be continued in 2 intervention groups (Levothyroxine made by Merck and Abureihan companies). Patients will be visited 6 and 8 weeks later to measure TSH and FT4 and assess therapy adherence and adverse effects. Drug dosage would be adjusted to maintain serum TSH concentration within 0.5-3 mU/l. Participants will be evaluated at baseline and two consequent follow-ups at six and eight weeks. At the first, second, and last visit at eight weeks, venous blood samples will be collected from all participants to measure serum TSH and FT4. Thyroid symptom questionnaires (TSQ) and thyroid treatment satisfaction questionnaires(ThyTSQ) will be filled out at the first and last visits (TSQ and ThyTSQ).To ensure compliance with drug therapy, the responsible person will check the drug package and count the number of pills intake by direct questioning in 2 weeks intervals by phone call and pill counting at the last visit, Randomization description: Patients are divided into two intervention groups based on cluster randomization. Six stratifications will be made based on age and gender. At first, patients will be assigned to three age groups of ≤50y, 51-70y, and &gt;70 y. Under each subgroup, patients will be assigned to male and female. Then under each sex subgroup, patients will be randomly assigned
to two treatment groups using the random table. Random sequences will be generated using Random-Allocation software, Blinding description: After performing randomization and special coding, subjects are assigned to groups using concealment, which helps keep physicians, participants, and researchers unaware of the type of treatment being assigned. Standard methods will be used to ensure concealment. Opaque containers will be numbered or coded in order. For single-center clinical trials such as the current trial, we select an expert who does not participate in the trial and can maintain a randomized list. This person is instructed to keep the list private and disclose treatment allocation only after receiving information indicating the patient is eligible and has consented to the trial. Subjects and researchers will be protected from knowing who will be assigned to which treatment (double-blind). Both groups will receive the same pills in appearance, taste, and smell.</study_design>
      <phase>2</phase>
      <hc_freetext>Hypothyroidism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group number one: This group will receive Levothyroxine pills made by Merck company. They will take 1.6 micro-gram per kg daily before breakfast for eight weeks. Intervention 2: Intervention group number two: This group will receive Levothyroxine pills made by Abureihan company. They will take1.6 micro-gram per kg daily before breakfast for eight 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 These data belong to Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atieh Amouzegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Institute for Endocrine Sciences,  Shahid Beheshti University of Medical Sciences, Erabi St, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2500</telephone>
        <email>amouzegar@endocrine.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atieh Amouzegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Center for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Erabi St, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2500</telephone>
        <email>amouzegar@endocrine.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>New patients with Hypothyroidism: serum TSH level should be 5.06-19.9 mIU/L and serum FT4 less than 0.91 ng/dL.
Only new patients who have never taken thyroid treatment.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women
People with underlying diseases such as liver failure, renal failure, heart failure
People with co-factors that can simulate hypothyroidism symptoms: Low Hgb, Vitamin D and B12 deficiency, and Depression
Taking any of the following medications during the trial: Methimazole, PTU, Tamoxifen, Drugs containing Estrogen and Progesterone, Corticosteroid, Gastrointestinal medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E03.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypothyroidism, 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 number one: This group will receive Levothyroxine pills made by Merck company. They will take 1.6 micro-gram per kg daily before breakfast for eight weeks.</i_keyword>
      <i_keyword>Intervention group number two: This group will receive Levothyroxine pills made by Abureihan company. They will take1.6 micro-gram per kg daily before breakfast for eight weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes of serum TSH level. Timepoint: First day, 6 weeks and 8 weeks after intervention. Method of measurement: Serum TSH and FT4 will be determined on blood samples by the Electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).</prim_outcome>
      <prim_outcome>Changes of serum FT4 level. Timepoint: First day, 6 weeks and 8 weeks after intervention. Method of measurement: Serum TSH and FT4 will be determined on blood samples by the Electrochemiluminescence immunoassay (ECLIA) method, using Roche Diagnostics kits and Roche/Hitachi Cobas e-411 analyzer (GmbH, Mannheim, Germany).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Thyroid symptoms. Timepoint: At the first and last visits. Method of measurement: Thyroid symptom questionnaire (TSQ).</sec_outcome>
      <sec_outcome>Treatment satisfaction. Timepoint: At the first and last visits. Method of measurement: Treatment satisfaction questionnaire (THY-TSQ).</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>Aburaihan pharmaceutical co.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-07</approval_date>
        <contact_name>Ethics committee of Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical</contact_name>
        <contact_address>Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Yaman St, Tehran Province, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
