<?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>IRCT20200115046136N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Radioprotective effect of ginseng in thyroid cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the protective effect of oral ginseng in patients with thyroid cancer following administration of high levels of radioactive iodine by measuring micronuclei and some biochemical factors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The simple method of randomization is with the dice tool.We throw dice for everybody, If number 1 and 2 come in group A, if number 3 and 4 come in group B, and if number 5 and 6, person falls into group C. In addition to the control group, there were two intervention groups and one placebo group. Names are put in sealed envelopes by someone other than the researcher, Blinding description: Patients are named in groups A, B, C, D and the person evaluating the patients does not know what group the patients are in and is kept blind to the study.The patient is also given a complete description of one of the treatment or control or placebo groups.</study_design>
      <phase>3</phase>
      <hc_freetext>thyroid cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The group received one capsule containing 500 mg of Korean Ginseng (Panax Ginseng) from Isfahan Ponic Medicines Company, completely herbal with no chemical additives the day before treatment.The ginseng root is a butter that is powdered and poured into the capsule and used orally. Intervention 2: Intervention group: Intervention group II: The subjects in this group receive one ginseng capsule one day before treatment and one day after treatment.The consumable material is pure powdered Ginseng root that is poured into the capsule.t is free of any chemical additives and is manufactured by Isfahan Ponic Drug Company. Intervention 3: Control group: Control group 1: Take one empty capsule as placebo one day before treatment. Intervention 4: Control group: The second control group received no supplementation and received routine treatment.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Reza fardid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedical School of Shiraz University of Medical Science, Meshkin fam Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3227 0238</telephone>
        <email>rfardid@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Reza Fardid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedical School of Shiraz University of Medical Science, Meshkin fam Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>0098712270238</telephone>
        <email>rfardid@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between the ages of 30 and 60 who had thyroid cancer and underwent thyroid surgery.
Patients who first receive radioactive iodine.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who have undergone radiotherapy or chemotherapy in the last year.
People with certain genetic diseases.
People taking medications for heart and kidney failure, and those who take Warfarin anticoagulants definitively.
People who smoke.
People who are radiant
People who have taken ginseng in the last month.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C73</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of thyroid gland</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The group received one capsule containing 500 mg of Korean Ginseng (Panax Ginseng) from Isfahan Ponic Medicines Company, completely herbal with no chemical additives the day before treatment.The ginseng root is a butter that is powdered and poured into the capsule and used orally.</i_keyword>
      <i_keyword>Intervention group: Intervention group II: The subjects in this group receive one ginseng capsule one day before treatment and one day after treatment.The consumable material is pure powdered Ginseng root that is poured into the capsule.t is free of any chemical additives and is manufactured by Isfahan Ponic Drug Company.</i_keyword>
      <i_keyword>Control group: Control group 1: Take one empty capsule as placebo one day before treatment.</i_keyword>
      <i_keyword>Control group: The second control group received no supplementation and received routine treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of micronuclei in lymphocytes of patients. Timepoint: At baseline (before intervention) and 48 hours after treatment. Method of measurement: Examination of lymphocytes of patients under the microscope after laboratory procedures.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA 96 kit.</sec_outcome>
      <sec_outcome>Ischemic modified albumin. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA method.</sec_outcome>
      <sec_outcome>The rate of malondialdehyde production in the process of oxidative stress. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA method.</sec_outcome>
      <sec_outcome>Evaluation of hepatic Alanine transaminase. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA method.</sec_outcome>
      <sec_outcome>Evaluation of hepatic enzyme Aspartate aminotransferase. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA method.</sec_outcome>
      <sec_outcome>Blood urea nitrogen test. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA method.</sec_outcome>
      <sec_outcome>Evaluation of Creatinine level. Timepoint: Before treatment and 48 hours after treatment. Method of measurement: Using the ELISA method.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-12</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Seventh Floor, Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
