<?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>IRCT201012055315N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-04-20</date_registration>
      <primary_sponsor>Vice chancellor for research,Shahed college of Medcine</primary_sponsor>
      <public_title>Effect of  Shebet Oil on Knee Arthrosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Shebet Oil and Diclofenac Gel on clinical symptoms in patients with Knee osteoarthritis: A randomized, double-blind, controlled Clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-07-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: shebet oil.&#13;
Knee local use.&#13;
Dosage 2 grams per use 3 times a day.&#13;
Patients will be visited at the 0, 2, 4 weeks of the study. Intervention 2: Pluse control group: diclofenac gel group.&#13;
Knee local use.&#13;
Dosage 2 grams per use 3 times a day.&#13;
Patients will be visited at the 0, 2, 4 weeks of the study.</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>Mahmood Khodadoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Legal Medicin organization, Behest Avenue, Parke Shar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5560 9071</telephone>
        <email>mkhodadoost@razi.tums.ac.ir; mkhodadoost2010@yahoo.com</email>
        <affiliation>Traditional Medcine College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahmood Khodadoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Legal Medicin organization, Behest Avenue, Parke Shar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5560 9071</telephone>
        <email>mkhodadoost@razi.tums.ac.ir; mkhodadoost2010@yahoo.com</email>
        <affiliation>Traditional Medcine College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion critria:&#13;
Patient's written consent for inclusion, Osteophyte in X.Ray, Knee pain Plus at least one of three: (Age&gt;50 year, Stiffness&lt;30 minutes, Crepitus).&#13;
Exclusion Critria:&#13;
Those who need more than 2 grams of acetaminophen ,Those who need to use other oral or intravenous analgesic ,Unwillingness to continue to participate in the study, Sensitivity to study drugs, Patients with other bone joint disorders:(Rhumatoid Arthrities, Gout,Pseudo Gout, Infected Arthrities, Metabolic Arthrities, Traumatic Arthrities), Joint Replacement, fibro Myalgia, Non-motor dysfunction related to hip or knee( Radiculopathy and Neuropathy), Concomitant use of glucosamine and chondrotin sulfate Knee Articular, Knee corticosteroid injection in the past 3 months, Other Articular corticosteroid injection in the past 1 months, Taking muscle relaxant drugs, Pregnancy, Oral and Local use of Corticosteroid in 14 past days, Mussle corticosteroid injection in the past 1 months&#13;
Alcohol addicted, Drug Abuse, Skin Diseases in Knee, Pationts with active Renal, Liver and Peptic Ulcer Diseases, Low dose Antidepressant user for chronic pain.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary arthrosis of other joints</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>shebet oil.&#13;
Knee local use.&#13;
Dosage 2 grams per use 3 times a day.&#13;
Patients will be visited at the 0, 2, 4 weeks of the study.</i_keyword>
      <i_keyword>Pluse control group: diclofenac gel group.&#13;
Knee local use.&#13;
Dosage 2 grams per use 3 times a day.&#13;
Patients will be visited at the 0, 2, 4 weeks of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Overall patient satisfaction. Timepoint: 2 Weeks. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Physical performance. Timepoint: 2 Weeks. Method of measurement: Womac Test.</prim_outcome>
      <prim_outcome>Stifness. Timepoint: 2WEEKS. Method of measurement: womac Test.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 2 Weeks. Method of measurement: Womac Test.</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>Vice chancellor for research,Shahed college of Medcine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-15</approval_date>
        <contact_name>Ethics Committee of Traditional Medcine College, Tehran University of Medical science</contact_name>
        <contact_address>Traditional Medcine College, Tehran University of Medical science, Farre danesh Alley, Ghods Avenue Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
