<?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>IRCT20210413050959N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-15</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the N compound  in the treatment of knee pain</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison of the effect of N and placebo on knee pain and function in patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55622</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The compound is made of olive oil, turmeric, coriander oil, and egg yolk. A study with these materials in combination is unprecedented, Randomization description: In random allocation, in order to select individuals and assign them to the two groups of control and intervention, three steps of access sampling, class allocation, and simple random allocation are respectively performed. To do this, first, people with osteoarthritis referred to the clinic and met the inclusion criteria are selected by available sampling. Since, in some cases, despite the application of stochastic programming, there is the possibility of heterogeneity in some initial features in the groups, the effective variables are excluded using the classification method. In this study, age and sex are very important factors in observing education; thus, to ensure the equal distribution of the two variables in the control and intervention groups, people with entry criteria are divided into four, men, women and 50 &gt;, &lt;50 years based on gender and age . Then, the samples divided into each class by a simple randomization method using the Randomization.com website, available to researchers for free, fall into intervention and control groups. For example, in women with age &gt;50, a list of random sequences such as the following is generated, and then, people are divided into two groups of intervention and control based on their number.
1. b____________________________________
2. a____________________________________
3. a____________________________________
4. b____________________________________
5. b____________________________________
6. b____________________________________
7. a________________________________________
8. b____________________________________
9. b____________________________________
10. a____________________________________
11. b____________________________________
12. a________________________________________
13. a____________________________________
14. a____________________________________
15. a________________________________________
16. b____________________________________, Blinding description: The drug used in both groups is the same in color and shape and is prepared in the laboratory by an expert. The container containing oil is filled with one of the two intervention substances or placebo and then is coded. Only the coder who does not participate in the study is aware of the attribution of the code to the intervention or placebo (usually a non-specific substance with a real medicinal shape, taste, and smell); the analysis is performed by another person. The medical staff of those who are somehow related to the samples do not know the type of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: N oil compound; The compound is made of olive oil, turmeric, coriander oil, and egg yolk by a traditional medicine pharmacist in Mashhad's Bouali laboratory, which is applied to the knee for 3 to 5 minutes daily. Intervention 2: Control group: The placebo (paraffin oil with a bright yellow pigment, similar to substance N) is synthesized by a traditional medicine pharmacist in the laboratory of Bouali Mashhad, who applies this drug to the knee for 3 to 5 minutes daily.</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 Because the result is not clear</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ali shamsi zaeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafsanjan University of Medical Sciences; Imam Ali Boulevard</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۷۱۷۹۳۳۷۷۷</zip>
        <telephone>00983434280041-238</telephone>
        <email>ft.amin@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali shamsi zaeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafsanjan University of Medical Sciences; Imam Ali Boulevard</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۷۱۷۹۳۳۷۷۷</zip>
        <telephone>0098 34 3280041-238</telephone>
        <email>ft.amin@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>45-70 years old
Confirmation of the disease by a rheumatologist according to the criteria of the American College of Rheumatology</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inflammatory disease
Disease the heart
Liver disease
Kidney disease
Allergy to herbal medicines
Smoking
Drug use
Painkillers uses
supplements and medicines uses
Daily painkillers uses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: N oil compound; The compound is made of olive oil, turmeric, coriander oil, and egg yolk by a traditional medicine pharmacist in Mashhad's Bouali laboratory, which is applied to the knee for 3 to 5 minutes daily.</i_keyword>
      <i_keyword>Control group: The placebo (paraffin oil with a bright yellow pigment, similar to substance N) is synthesized by a traditional medicine pharmacist in the laboratory of Bouali Mashhad, who applies this drug to the knee for 3 to 5 minutes daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee pain. Timepoint: before intervention and after intervention. Method of measurement: Visual Analogue Scale (VAS) and WOMAC (Western Ontario and Mc Master) questionnaire.</prim_outcome>
      <prim_outcome>The joints morning stiffness. Timepoint: before intervention and after intervention. Method of measurement: Visual Analogue Scale (VAS) and WOMAC (Western Ontario and Mc Master) questionnaire.</prim_outcome>
      <prim_outcome>The Knee range of motion. Timepoint: before intervention and after intervention. Method of measurement: Visual Analogue Scale (VAS) and WOMAC (Western Ontario and Mc Master) questionnaire.</prim_outcome>
      <prim_outcome>The Knee function. Timepoint: before intervention and after intervention. Method of measurement: Visual Analogue Scale (VAS) and WOMAC (Western Ontario and Mc Master) questionnaire.</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>2021-07-10</approval_date>
        <contact_name>Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Rafsanjan University of Medical Sciences; Imam Ali Boulevard Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
