<?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>IRCT20120415009472N30</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-13</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Sumac on rheumatoid arthritis</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the Effects of Sumac Supplementation on Disease Activity, Inflammatory Markers, and Immunomodulatory Factors in Patients with Rheumatoid Arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/90701</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomly selected from patients referred to a rheumatologist at Zarrinkoub Clinic. After meeting the eligibility criteria, participants will be randomly allocated to either the intervention or control group using block randomization generated by STATA software. Randomization will be stratified by age (20–40 years and 40–60 years) and sex to ensure comparability between the two groups. A total of 96 eligible participants will be randomly assigned to 24 blocks of four subjects each. Random block sequences (Groups A and B) will be generated using STATA software or the Sealed Envelope randomization website and provided to the researcher, Blinding description: Sumac or placebo will be coded by a third party who is unaware of the contents of the packages. None of the participants, nor the researcher or analyst, will be aware of the groups (sumac or placebo) and the type of intervention (sumac or placebo), and the packages containing the powder will be supplied by the company, as well as the placebo and sumac packages, in terms of internal and external appearance. After data analysis, the pharmaceutical company will be asked for the label title (drug or placebo) to compile the report and write the findings section.</study_design>
      <phase>2</phase>
      <hc_freetext>Patients with Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 48 people in the group receiving 1000 mg of sumac capsules (3 per day, after each meal). Intervention 2: Control group: 48 people in the group receiving lactose placebo capsules (capsules made completely identical in appearance, color, smell, taste and without therapeutic effect, 3 per day, after each meal).</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naheed Aryaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition department, school of public health, Hemmat broad way</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4750</telephone>
        <email>aryaeian.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naheed Aryaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition department, school of public health, Hemmat broad way</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4750</telephone>
        <email>aryaeian.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 60 years; diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria (presence of at least 4 of the following criteria for a minimum of 6 weeks: 1) morning stiffness lasting at least 1 hour, 2) arthritis in three or more joint areas, 3) arthritis of hand joints, 4) symmetric arthritis, 5) rheumatoid nodules, 6) positive rheumatoid factor, and 7) typical radiographic changes in the wrists and hands); disease duration of at least 1 year; and no changes in medication regimen during the previous 2 months. The patient expresses his / her consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smoking; use of nutritional or antioxidant supplements within one month prior to the study; pregnancy or lactation; history of diabetes or other chronic diseases; history of other autoimmune diseases; changes in medication regimen during the past month; and adherence to special dietary regimens.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Rheumatoid</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M05</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: 48 people in the group receiving 1000 mg of sumac capsules (3 per day, after each meal)</i_keyword>
      <i_keyword>Control group: 48 people in the group receiving lactose placebo capsules (capsules made completely identical in appearance, color, smell, taste and without therapeutic effect, 3 per day, after each meal)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TNF-α. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Immunoturbidometric method.</prim_outcome>
      <prim_outcome>Interferon gamma (IFN-γ). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Total antioxidant capacity (TAC). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Chromatography.</prim_outcome>
      <prim_outcome>Erythrocyte sedimentation rate (ESR). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Westergren method.</prim_outcome>
      <prim_outcome>Matrix Metalloproteinases. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Calprotectin. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Interleukin-17 (IL-17). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Zonulin. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Lipopolysaccharide. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Disease activity score. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Formula DAS28.</prim_outcome>
      <prim_outcome>Illness severity. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Physician global assessment.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Morning stiffness. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: How long (minutes) it takes for the joint dryness to go away.</prim_outcome>
      <prim_outcome>Number of painful joints. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Doctor's examination.</prim_outcome>
      <prim_outcome>Tender joint counts (TJC). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Doctor's examination.</prim_outcome>
      <prim_outcome>Swollen joint count. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Doctor's examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dosage of drugs. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-02</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Research and Technology Vice-Chancellor, Central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
