<?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>IRCT20190407043194N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of propolis on rheumatoid arthritis</public_title>
      <acronym></acronym>
      <scientific_title>Determining the Effect of Propolis Supplementation on Inflammatory Factors and Oxidative Status in Women  with Rheumatoid Arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49430</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will allocate in each group by:
Allocation will randomize in  blocks of size 4 (two placebos,two propolis) will design by RAS software. Each block will stratify by patient's baseline characteristics of body mass index (less or more than 30 kg/m²), Severity of disease (moderate or sever) and menstrual status (yes or no), Blinding description: In this study investigator and participants are blind from groups and how they are randomized.</study_design>
      <phase>3</phase>
      <hc_freetext>Arthritis rheumatoid.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Propolis supplement (Propolis supplement capsule containing 500 mg of propolis, Shahdineh Golha Pharmaceutical Company, 2 times a day, daily consumption for 3 months, with water). Intervention 2: Control group: Placebo (placebo capsule containing 500 mg of wheat starch, Shahdineh Golha Pharmaceutical Company, 2 times a day, daily consumption for 3 months, with water).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Primary outcomes will be share.

When:
Starting 6 month after publication

To whom:
Researchers

Conditions:
For Metanalysis

Where to obtain:
Making contact with Dr. Mariam Khosravi

How to obtain:
Making contact with Dr. Mariam Khosravi and asking for the data, if she approved, request will be send to university president, if they approved the data will send for applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, medicine School, Mashhad University of Medical Sciences, Univesity campus, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2367</telephone>
        <email>Khosravim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, medicine School, Mashhad University of Medical Sciences, Univesity campus, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2367</telephone>
        <email>khosravim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People in the age range of 20-70 years
Patients with moderate and severe disease activity score 28
Do not take antioxidant supplements for at least 1 month before starting the study
The tendency to cooperate and sign informed written consent
Diagnosis of the disease by a rheumatologist based on the criteria of the American College of Rheumatology</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy and lactation
Taking oral contraceptive pills
History of chronic diseases such as diabetes mellitus, kidney failure, liver failure and cancer
Having other autoimmune and inflammatory diseases
Having Hormonal disorders, thyroid disorders
Alcohol consumption and hookah smoke
Smoking and being exposed to secondhand smoke</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Propolis supplement (Propolis supplement capsule containing 500 mg of propolis, Shahdineh Golha Pharmaceutical Company, 2 times a day, daily consumption for 3 months, with water).</i_keyword>
      <i_keyword>Control group: Placebo (placebo capsule containing 500 mg of wheat starch, Shahdineh Golha Pharmaceutical Company, 2 times a day, daily consumption for 3 months, with water).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Interleukin 17. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Total oxidant status. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Tumor necrosis factor alpha. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Glutathione peroxidase. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Catalase. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and after of intervention. Method of measurement: Laboratory test.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: Before and after of intervention. Method of measurement: Laboratory test.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: Before and after of intervention. Method of measurement: Laboratory test.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before and after of intervention. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Dietary intake. Timepoint: Before and after of intervention. Method of measurement: Three days food record.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: Before and after of intervention. Method of measurement: International Physical Activity Questionnaire.</prim_outcome>
      <prim_outcome>Anthropometric measurements. Timepoint: Before and after of intervention. Method of measurement: Body mass index, waist circumference, Hip circumference.</prim_outcome>
      <prim_outcome>High sensivity C-reactive protein. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Monocyte Chemoattractant Protein-1. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: Before and after of intervention. Method of measurement: Elisa kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-05</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Nutrition Department, Medicine School, Mashhad University of Medical Sciences, University campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
