<?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>IRCT20221127056629N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-18</date_registration>
      <primary_sponsor>sirjan school of medical science</primary_sponsor>
      <public_title>The effect of licorice administration on patients with rheumatoid arthritis</public_title>
      <acronym></acronym>
      <scientific_title>The effects of licorice supplementation on clinical symptoms and inflammatory markers in patients with active rheumatoid arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups of intervention (38 patients) and placebo (38 patients). Supplement and placebo will be placed in similar containers by someone outside the study based on the corresponding codes written on the containers. Supplement or placebo recipients will be assigned based on entry code. In this double-blind study, the factors that can distort the results of the experiment, such as information about receiving a supplement or placebo, will remain hidden from both the participants (patients) and the researcher, Blinding description: Supplement and placebo will be placed in similar containers by someone outside the study based on the corresponding codes written on the containers. Supplement or placebo recipients will be assigned based on entry code. In this double-blind study, the factors that can distort the results of the experiment, such as information about receiving a supplement or a placebo, will remain hidden from both the participants (patients) and the researcher.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Rheumatoid arthritis patients who received capsules containing 0.5 mg of licorice prepared by Iran Daruk Company 3 times a day for 8 weeks. Intervention 2: Control group: Rheumatoid arthritis patients receiving capsules containing placebo, prepared by Iran Daruk Company, receive orally 3 times 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>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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad amin serpoosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ibn sina street , sirjan school of medical sicence</address>
        <city>sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7816916338</zip>
        <telephone>+98 34 4223 4513</telephone>
        <email>aminsrps@gmail.com</email>
        <affiliation>sirjan school of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr mahmood reza masoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ibn sina street sirjan school of medical science</address>
        <city>sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7816916338</zip>
        <telephone>+98 34 4223 4513</telephone>
        <email>Masoodi85@yahoo.com</email>
        <affiliation>sirjan school of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with joint rheumatism referring to Sirjan Faculty of Medical Sciences clinic
Filling the consent form by patients</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart, kidney or hypertension patients, history of heart attack, high blood lipids, abnormal kidney or liver function, use of non-steroidal anti-inflammatory drugs, use of vitamins and/or mineral supplements and drugs such as thyroid hormones, anti-hypertensive drugs Blood, contraceptives, diuretics and beta-blockers, as well as alcohol consumption, smoking, pregnancy and breastfeeding
Other underlying diseases and also it should be mentioned that each person participating in the study will be excluded from the study in case of discontinuation of treatment or side effects caused by the consumption of licorice.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis with rheumatoid factor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Rheumatoid arthritis patients who received capsules containing 0.5 mg of licorice prepared by Iran Daruk Company 3 times a day for 8 weeks.</i_keyword>
      <i_keyword>Control group: Rheumatoid arthritis patients receiving capsules containing placebo, prepared by Iran Daruk Company, receive orally 3 times a day for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease severity. Timepoint: 0،90. Method of measurement: Disease activity score 28 ( DAS28).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Erythrocyte sedهmentation rate. Timepoint: 0،90. Method of measurement: Westergren method.</sec_outcome>
      <sec_outcome>Intensity of pain. Timepoint: 0،90. Method of measurement: The patients will be asked to mark their pain level from their point of view on a ten-point scale.</sec_outcome>
      <sec_outcome>CRP. Timepoint: 0,90. Method of measurement: Agglutination method.</sec_outcome>
      <sec_outcome>TNF-α. Timepoint: 0,90. Method of measurement: Eliza method.</sec_outcome>
      <sec_outcome>IL-6. Timepoint: 0,90. Method of measurement: Eliza method.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: 0,90. Method of measurement: by barometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: 0,90. Method of measurement: by barometer.</sec_outcome>
      <sec_outcome>AST. Timepoint: 0,90. Method of measurement: Colorimetric method and photometer.</sec_outcome>
      <sec_outcome>Licorice. Timepoint: 0,90. Method of measurement: by scales.</sec_outcome>
      <sec_outcome>Potassium. Timepoint: 0,90. Method of measurement: Flynn photometry method.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: 0،90. Method of measurement: Colorimetric method and photometer.</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>sirjan school of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-19</approval_date>
        <contact_name>کمیته اخلاق دانشکده علوم پزشکی سیرجان</contact_name>
        <contact_address>Ibn Sina St., Sirjan school of Medical Sciences sirjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
