<?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>IRCT201208241197N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-14</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Whole fruit and medolla powder of Elaeagnus angustifolia effect on osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of whole fruit and medolla powder of Elaeagnus angustifolia supplementation on clinical manifestation, inflammatory factors, matrix metalloproteinase enzymes, oxidative stress and nutritional status of patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/408</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This is a double blind study in which the researcher and patients will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in doing the assessment and chemical analysis. Patients will be informed about the type of supplements (whole fruit and medolla powder of Elaeagnus angustifolia and placebo) however they will not be aware about the group assignments.</study_design>
      <phase>3</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Oral administration of 15 grams whole fruit powder of Elaeagnus angustifolia (prepared by the researcher) for 8 weeks. Intervention 2: Intervention 2: Oral administration of 15 grams medolla powder of Elaeagnus angustifolia (prepared by the researcher) for 8 weeks. Intervention 3: Intervention3: Oral administration of 15 grams corn starch+Isomaltose 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Nikniaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition faculty, Tabriz University of Medical Sciences, Tabriz-Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1334 1113</telephone>
        <email>znikniaz@hotmail.com</email>
        <affiliation>Nutrition faculty, Tabriz University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Mahdavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition faculty, Tabriz University of Medical Sciences, Tabriz-Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1334 1113</telephone>
        <email>mahdavirez@hotmail.com</email>
        <affiliation>Nutrition research center, nutrition faculty, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
1.Female&#13;
2.Age: 40-70 years&#13;
3.Bilateral primary osteoarthritis of knee (according to ACR classification)&#13;
4.Body mass index of 25-29.9&#13;
     &#13;
Exclusion criteria:&#13;
1.Secondary osteoarthritis&#13;
2.Active synovitis&#13;
3.Neurological disorder that affects movement, muscle control and balance&#13;
4.Uncontrolled hypertension, diabetes, cardiovascular disorders, chronic kidney disorders and functional liver disorders&#13;
5.Using Frosemid, Probenecid, Anticoagulants, Hydantoin, Sulfonamides, Methotrexate, Lithium salts, Beta blockers and muscle relaxants&#13;
6.Smoking&#13;
7.Having an allergic reaction to Elaeagnus angustifolia &#13;
8. Daily use of Elaeagnus Angustifolia</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M-17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bilateral primary osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: Oral administration of 15 grams whole fruit powder of Elaeagnus angustifolia (prepared by the researcher) for 8 weeks</i_keyword>
      <i_keyword>Intervention 2: Oral administration of 15 grams medolla powder of Elaeagnus angustifolia (prepared by the researcher) for 8 weeks</i_keyword>
      <i_keyword>Intervention3: Oral administration of 15 grams corn starch+Isomaltose for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Onset and after the study. Method of measurement: WOMAC questionnaire.</prim_outcome>
      <prim_outcome>Joint stiffness. Timepoint: Onset and after the study. Method of measurement: WOMAC questionnaire.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Onset and after the study. Method of measurement: WOMAC questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Plasma total antioxidant capacity and MDA level. Timepoint: Onset and at the end of the study. Method of measurement: Antioxidant capacity = Randox kit, MDA= Fluorometry.</sec_outcome>
      <sec_outcome>Serum  IL-1, IL-10 and TNF-alpha  levels. Timepoint: Onset and at the end of the study. Method of measurement: IL-1:ELISA kit; IL-10:ELISA kit; TNF-alpha: ELISA kit.</sec_outcome>
      <sec_outcome>Serum MMP-1 and MMP-13  levels. Timepoint: Onset and at the end of the study. Method of measurement: MMP-1:ELISA kits; MMP-13:ELISA kit.</sec_outcome>
      <sec_outcome>Nutritional status and dietary intake. Timepoint: Onset and at the end of the study. Method of measurement: Dietary intake: 24 hours questionnaires; Nutritional status: Weight: Standard scale, Height: Stadiometer.</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>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-07</approval_date>
        <contact_name>Ethic committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht Street, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
