<?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>IRCT20170514033961N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-23</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of olive extract on arthrosis of the knee</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hydroalcoholic extract of olive leaf on osteoarthritis of the knee and daily functioning of the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53755</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: The samples included in the study are placed in four groups using random stratified blocking method. The method of allocating 120 eligible samples in 4 groups of 30 is as follows, taking into account the sex class (male and female) and in A total of 4 floors are formed. Within each class, the method of 4 random blocks is used to assign patients to the four groups studied. To do this, first write the list of blocks and assign numbers to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) then using A table of random numbers will be assigned to them at random, and finally a list of treatment assignments will be formed based on a sequence of letters A and B.</study_design>
      <phase>2</phase>
      <hc_freetext>osteoarthrit.</hc_freetext>
      <i_freetext>Intervention group 1: For intervention in this group, high quality olive leaf extract ointment of coronaci species prepared by Danakasia company is provided to the research samples and they will be trained to use 15 ml of it topically in the tibiofemoral area three times a day for eight weeks. Also continue their routine treatment during the intervention period, which includes taking acetaminophen 500 mg tablets every eight hours.Intervention group 2: Capsules containing 60 mg of high quality olive leaf extract powder of Cronaci species prepared by Danacasia company will be provided to the research samples and they will be trained to take it orally with each meal three times a day for eight weeks and also during the course. Continue your routine treatment intervention, which includes taking acetaminophen 500 mg tablets every eight hours.Intervention group 3: Capsules containing high quality olive leaf extract along with ointment containing olive leaf extract prepared by Danakasiarad company are provided with research samples and they will be trained to take them orally with food every day for eight weeks and three times a day, respectively. Topically in the tibiofemoral area and also during the intervention period, continue their routine treatment, which includes taking acetaminophen 500 mg tablets every eight hours. Intervention group 4: Take routine treatment, including taking acetaminophen 500 mg tablets every eight hours, and do not use any other medicine to relieve this drug..</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:
All potential data is released after unidentifiable individuals in the form of original message information.

When:
The access period will start from 2021

To whom:
All researchers, lecturers, medical students can receive the published article from the relevant journal.

Conditions:
Unidentifiable data will be made available to health researchers for the study of meta-analysis.

Where to obtain:
end email to Mandanasaki.m.saki@modares.ac.ir

How to obtain:
After sending the documents by the applicant researcher via email, the data will be sent two weeks later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>saki mandana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Rose Alley, Enghelab St., Lorestan, Khorramabad</address>
        <city>Khorram abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819834525</zip>
        <telephone>+98 66 3331 6465</telephone>
        <email>mandana-saki@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mandana saki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Rose Alley,Enghelab St.Khorramabad, Lorestan,</address>
        <city>KHorram abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819834525</zip>
        <telephone>+98 66 3331 6465</telephone>
        <email>mandana-saki@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The individual's desire to participate in the study
Being 60-80 years old
Diagnosis of primary osteoarthritis of the knee Participating in the study based on the diagnosis of an orthopedic specialist (based on the description of clinical symptoms, physical examination, radiographic criteria and diagnostic properties related to the disease)
Have Osteoarthritis Grade 1-3 Based on American College of Rheumatology Classification Criteria
Having moderate pain according to visual analog criteria (4-7)
No dependence on others in performing daily activitiesFailure to perform physiotherapy and surgery in the last 12 months
No intra-articular injection of steroids in the last 6 months
Having a body mass index of less than 30
Have a performance score above 34
No neurological diseases associated with movement and balance disorders</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Creating acute medical conditions
The death of the elderly at the time of study
Reluctance to continue participating in the study
Sensitivity to olives
Existence of cognitive disorders
Secondary osteoarthritis in rheumatologydiseases (such as rheumatoid arthritis, gout, infectious arthritis, metabolic arthritis, traumatic arthritis)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: For intervention in this group, high quality olive leaf extract ointment of coronaci species prepared by Danakasia company is provided to the research samples and they will be trained to use 15 ml of it topically in the tibiofemoral area three times a day for eight weeks. Also continue their routine treatment during the intervention period, which includes taking acetaminophen 500 mg tablets every eight hours.Intervention group 2: Capsules containing 60 mg of high quality olive leaf extract powder of Cronaci species prepared by Danacasia company will be provided to the research samples and they will be trained to take it orally with each meal three times a day for eight weeks and also during the course. Continue your routine treatment intervention, which includes taking acetaminophen 500 mg tablets every eight hours.Intervention group 3: Capsules containing high quality olive leaf extract along with ointment containing olive leaf extract prepared by Danakasiarad company are provided with research samples and they will be trained to take them orally with food every day for eight weeks and three times a day, respectively. Topically in the tibiofemoral area and also during the intervention period, continue their routine treatment, which includes taking acetaminophen 500 mg tablets every eight hours. Intervention group 4: Take routine treatment, including taking acetaminophen 500 mg tablets every eight hours, and do not use any other medicine to relieve this drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee pain score. Timepoint: The beginning of the study, the second, fourth, sixth, eighth week. Method of measurement: Visual Analog Scale,.</prim_outcome>
      <prim_outcome>Joint dryness score. Timepoint: The beginning of the study, the second, fourth, sixth, eighth week. Method of measurement: Osteoarthritis Index of West Ontario University and McMaster.</prim_outcome>
      <prim_outcome>Psychological performance score. Timepoint: The beginning of the study, the second, fourth, sixth, eighth week. Method of measurement: Osteoarthritis Index of West Ontario University and McMaster.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-17</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Science</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Lorestan, Khorramabad, Road, Pardis University Complex University of Medical Sciences, KHorramabd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
