<?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>IRCT20180923041097N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-01</date_registration>
      <primary_sponsor>The University of Sistan and Baluchestan</primary_sponsor>
      <public_title>Effect of aerobic exercise and garlic consumption on rheumatoid arthritis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of aerobic exercise and garlic supplementation on fatigue and cardiovascular risk factors in women with rheumatoid arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Random allocation is done by simple randomization method. First, 3 groups based on the number of participants in each group and the number of groups required for the trial (placebo, exercise, exercise and placebo), are formed and then a 2 digit code is given to each subject without any criteria from 01 to 48. Then a number is selected in the table of random numbers, with the eyes closed, and in the row to the right of the desired number, up to 16 two-digit numbers less than 48 for the first group, 16 second two-digit numbers for the second group and 16 third two-digit numbers for the third group will be considered, Blinding description: In the present trial, there are two groups of exercise, one receiving supplement and the other receiving placebo. The Supervisor is the only one who is aware of the contents of the capsules containing the supplement and placebo, and provides these capsules to the evaluator students for the use of the subjects in the supplement and exercise + supplement groups. Thus, participants, evaluators and statistical analysts do not know which group is a exercise group and which group is a exercise + supplement group.</study_design>
      <phase>2</phase>
      <hc_freetext>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: This group pedals on the ergometer (Body  sculpture brand made in China)for eight weeks, 3 sessions per week, in each session after 10 minutes of warm-up, with an intensity of 70% of the maximum oxygen consumption, and then cools down for 10 minutes and daily receives 2 rounds of placebo (corn starch under the Zamen brand, manufactured by Etminan Hadaf Toos Company, which was prepared in the amount of 500 mg in coatings similar to garlic supplement capsules by the researcher). Intervention 2: Second intervention group: This group pedals on the ergometer for eight weeks, 3 sessions per week and in each session after 10 minutes of warm-up, with an intensity of 70% of the maximum oxygen consumption, and then cools down for 10 minutes. Take 2 times a day garlic supplement with Garcin brand made by Goldaro company, Iran in a dose of 500 mg. Intervention 3: Third intervention group: This group receives 500 mg of garlic supplement(with brand of Garcin produced by Gol daro Company), twice a day 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Subjects' information is shared with other researchers after being Unrecognizable.

When:
After the publication of the final research report.

To whom:
Academic researchers

Conditions:
Citing the findings by citing the source

Where to obtain:
By email address

How to obtain:
After receiving the request via email and reviewing the request by the scientific officer of the research, will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Delavar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Sports Sciences, Sistan and Baluchestan University, University Street.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816745845</zip>
        <telephone>+98 54 3113 2674</telephone>
        <email>delavar@ped.usb.ac.ir</email>
        <affiliation>The University Sistan and Baluchestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza ِDelavar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Sport Sciences, Faculty of Psychology and Educational Sciences, University of Sistan and Baluchestan, , University Blvd.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816745845</zip>
        <telephone>+98 54 3113 6724</telephone>
        <email>delavar@ped.usb.ac.ir</email>
        <affiliation>University of Sistan and Baluchestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with rheumatoid arthritis
Women with rheumatoid arthritis who are of childbearing age.
Women with rheumatoid arthritis aged 27 to 45 years.</inclusion_criteria>
      <agemin>27 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with rheumatoid arthritis who also have cardiovascular disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05.04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Felty's syndrome, hand</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: This group pedals on the ergometer (Body  sculpture brand made in China)for eight weeks, 3 sessions per week, in each session after 10 minutes of warm-up, with an intensity of 70% of the maximum oxygen consumption, and then cools down for 10 minutes and daily receives 2 rounds of placebo (corn starch under the Zamen brand, manufactured by Etminan Hadaf Toos Company, which was prepared in the amount of 500 mg in coatings similar to garlic supplement capsules by the researcher).</i_keyword>
      <i_keyword>Second intervention group: This group pedals on the ergometer for eight weeks, 3 sessions per week and in each session after 10 minutes of warm-up, with an intensity of 70% of the maximum oxygen consumption, and then cools down for 10 minutes. Take 2 times a day garlic supplement with Garcin brand made by Goldaro company, Iran in a dose of 500 mg.</i_keyword>
      <i_keyword>Third intervention group: This group receives 500 mg of garlic supplement(with brand of Garcin produced by Gol daro Company), twice a day for eight weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure above 14 mm Hg. Timepoint: 24 hours before and 24 hours after the first and last session of the exercise program. Method of measurement: By arm blood pressure monitor.</prim_outcome>
      <prim_outcome>Total cholesterol above 250 mg per deciliter. Timepoint: 24 hours before and 24 hours after the first and last session of the exercise program. Method of measurement: Total cholesterol diagnostic kit made by Pars Azmoun company by photometric method.</prim_outcome>
      <prim_outcome>Blood LDL level above 160 mg per deciliter. Timepoint: 24 hours before and 24 hours after the first and last session of the exercise program. Method of measurement: Low density lipoprotein diagnostic kit made by Pars Azmon Company by photometric method.</prim_outcome>
      <prim_outcome>Fatigue rate above 3 points. Timepoint: 24 hours before and 24 hours after the first and last session of the exercise program. Method of measurement: Fatigue Symptom Inventory questionnaire.</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>The University of Sistan and Baluchestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-02</approval_date>
        <contact_name>Ethics Committee of Sistan and Baluchestan University.</contact_name>
        <contact_address>Central Organization of Sistan and Baluchestan University, University Blvd, Zahedan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
