<?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>IRCT20180811040759N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-19</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of achillea millefolium oil on some clinical symptom of knee joint osteoarthritis: a randomized and double blind clinical trial double- blind study</public_title>
      <acronym></acronym>
      <scientific_title>The effect of achillea millefolium oil on some clinical symptom of knee joint osteoarthritis: a randomized and double blind clinical trial double- blind study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a table of random numbers, they are randomly divided into one of three groups: the treatment group (receiving achillea millefolium oil (Oil Seed Company)), the control group (paraffin) and the receiving group of piroxicam gel, Blinding description: Controlled double-blinds (patient not knowing about and completing evaluation of checklists of the type of drug used) will be performed.The duration of the massage is 3 to 5 minutes daily and the duration of taking the medicine is 2 months.The drugs are coded by someone other than the investigator and will be delivered to the Physician. Clinical examinations and confirmation of the disease are performed by a rheumatologist and subsequent evaluations are performed under the supervision of a rheumatologist and by an internal resident who will be unaware of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1 (27 Individuals) will use achillea millefolium oil. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed. Intervention 2: Control group: Group 2 (Placebo) (27 individuals). The form and type of the drug is the same. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed. Intervention 3: Intervention group: Group 3 will receive Piroxicam gel. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed.</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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Abbasifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Ali Ave, rafsanjan university of medical sciense</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717937555</zip>
        <telephone>+98 34 3428 0040</telephone>
        <email>dr.mabbasifard@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Abbasifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Ali Ave, rafsanjan university of medical sciense</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717937555</zip>
        <telephone>+98 34 3428 0040</telephone>
        <email>dr.mabbasifard@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Awareness consent to participate in the study
Moderate to severe pain intensity visual linear scale of pain
Age 45-70 years
The diagnosis of osteoarthritis of the knee is based on the diagnostic criteria of the American College of Rheumatology and the confirmation of the rheumatologist's diagnosis by a rheumatologist
Existence of moderate pain in the knee during 24 hours based on the linear-visual scale of pain between 4-7 cm</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue participating in the study
Non-compliance with the study protocol
Observe any side effects that the patient thinks were caused by yarrow oil after the start of the study
Taking vitamin, mineral or other nutritional supplements and taking painkillers</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>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1 (27 Individuals) will use achillea millefolium oil. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed</i_keyword>
      <i_keyword>Control group: Group 2 (Placebo) (27 individuals). The form and type of the drug is the same. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed</i_keyword>
      <i_keyword>Intervention group: Group 3 will receive Piroxicam gel. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients in all groups, are only allowed to use oral analgesics without anti-inflammatory effect such as acetaminophen once daily if needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee pain intensity. Timepoint: At the beginning and the end of the study (two months after the beginning of the study). Method of measurement: Visual Analogue Scale (VAS) And WOMAC index.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-13</approval_date>
        <contact_name>Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
