<?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>IRCT20180802040671N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-28</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effectiveness of two methods localized heat therapy and kldrab gel on symptoms and joint function in patients with knee erosion</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effectiveness of two methods localized heat therapy and kldrab gel on symptoms and joint function in patients with knee erosion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33173</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be simple random and will continue until reaching the sample size. The samples will be assigned to two experimental groups (the Kelderab gel intervention group, the Therapy group) and a control group (three groups) based on randomized block assignment.</study_design>
      <phase>3</phase>
      <hc_freetext>KNEE EROSION.</hc_freetext>
      <i_freetext>Intervention 1: The protocol of using Kelderab gel: In case group 1, a combination topical gel in the knee area is used before the application of topical gel in case group 1, symptoms and performance status are assessed by the researcher using the wear and tear injuries inventory questionnaire. In the case group 1, the ointment containing eucalyptus, menthol and camphor (clodrub ointment, manufactured by Gol Dara Company, Iran) is supplied to the patients. Each patient should use it daily twice a day. Treatment lasts for 4 weeks. Patients undergo weekly evaluations using wear and tear injuries questionnaire. Intervention 2: Prototype of hot water bag: In group 2, a hot water bag is used in the knee area at 55 ° C. Before the intervention, symptoms and functional status of the patients are examined using a questionnaire together with the researcher. Subsequently, the intervention group Treatment with a warm water bag daily is treated twice daily for up to 20 minutes each time for 4 weeks. Patients are evaluated weekly by using a questionnaire. Intervention 3: Control group: no interventionControl group:There will be no intervention in the control group. Patients in this group received routine care and only the research tools will be completed.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moslem Ariana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golzar Street</address>
        <city>Dehdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7571845449</zip>
        <telephone>+98 74 3226 8646</telephone>
        <email>MOSKEM.ARIANA@YUMS.AC.IR</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Martyr Motahhari</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7571845449</zip>
        <telephone>+98 74 1223 1556</telephone>
        <email>MOSLEM.ARIANA@YUMS.AC.IR</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient's willingness to participate in the study
Age range from 45 to 60 years
Certified orthopedic practitioner
Creatine keratinization in knee joint active movement, morning dryness less than 30 minutes, movement constraints, knee pain in most days of the last month</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient's refusal to continue cooperation, immigration of the patient from the study site
Patient death
Immigration of the patient from the study site</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis, unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The protocol of using Kelderab gel: In case group 1, a combination topical gel in the knee area is used before the application of topical gel in case group 1, symptoms and performance status are assessed by the researcher using the wear and tear injuries inventory questionnaire. In the case group 1, the ointment containing eucalyptus, menthol and camphor (clodrub ointment, manufactured by Gol Dara Company, Iran) is supplied to the patients. Each patient should use it daily twice a day. Treatment lasts for 4 weeks. Patients undergo weekly evaluations using wear and tear injuries questionnaire.</i_keyword>
      <i_keyword>Prototype of hot water bag: In group 2, a hot water bag is used in the knee area at 55 ° C. Before the intervention, symptoms and functional status of the patients are examined using a questionnaire together with the researcher. Subsequently, the intervention group Treatment with a warm water bag daily is treated twice daily for up to 20 minutes each time for 4 weeks. Patients are evaluated weekly by using a questionnaire.</i_keyword>
      <i_keyword>Control group: no interventionControl group:There will be no intervention in the control group. Patients in this group received routine care and only the research tools will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>KNEE EROSION. Timepoint: 1MONTHS. Method of measurement: QUESTIONNAIRE.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>STINGINESS. Timepoint: 1MONTHS. Method of measurement: QUESTIONAIRE.</sec_outcome>
      <sec_outcome>PAIN. Timepoint: 1 MONTH. Method of measurement: QUESTIONAIRE.</sec_outcome>
      <sec_outcome>SWELLING. Timepoint: 1MONTHS. Method of measurement: QUESTIONAIRE.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-21</approval_date>
        <contact_name>Ethics committee of yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj motahari blvd Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
