<?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>IRCT20180827040884N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-20</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of topical products extracted from essential oils of Capsicum, Apium graveolens and Mentha plants on the pain intensity in patients with skeletal inflammatory pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of topical products extracted from essential oils of Capsicum, Apium graveolen and Menth plants on the pain intensity in patients with skeletal inflammatory pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: First, each patient referred to the clinic was given a special code. All the codes were placed in a container. Then, three envelopes named (A), (B), (C) were selected and given to patients as a blind strain.Then, by drawing lots from the patient code container, a piece of paper was taken out and the desired code was selected from one of the envelopes and the desired intervention group was identified. After the intervention group was identified, the specified code was returned to the code container. So that all participants have an equal chance to choose the intervention group. This work continued until reaching the desired sample size, Blinding description: The drug was delivered to patients with identical tubes that had only a specific code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Skeletal inflammatory pain.</hc_freetext>
      <i_freetext>Intervention 1: The drug was delivered to patients with identical tubes that had only a specific code, and it was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage.First intervention group received  a solution by the name of the CM(Mint and  Celery )which was prepared Barij  Essence Pharmaceutical Company. Intervention 2: The second  intervention group received   Capex ointment which was prepared Barij  Essence Pharmaceutical Company. It was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage. Intervention 3: The third  intervention group received, combined solution( Capex ointment and CM)   which was prepared Barij  Essence Pharmaceutical Company. It   was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage .</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh  taghlili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gorgiabad., Islamic Azad University of Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4715763561</zip>
        <telephone>+98 11 3241 5163</telephone>
        <email>fa_taghlili@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Taghlili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gorgiabad., Islamic Azad University of Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4715763561</zip>
        <telephone>+98 11 3241 5163</telephone>
        <email>fa_taghlili@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients  40 – 70 years
without other bone diseases
Dont pregnancy and breastfeeding
The lack of drug interactions</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of other topical analgesics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The drug was delivered to patients with identical tubes that had only a specific code, and it was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage.First intervention group received  a solution by the name of the CM(Mint and  Celery )which was prepared Barij  Essence Pharmaceutical Company.</i_keyword>
      <i_keyword>The second  intervention group received   Capex ointment which was prepared Barij  Essence Pharmaceutical Company. It was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage.</i_keyword>
      <i_keyword>The third  intervention group received, combined solution( Capex ointment and CM)   which was prepared Barij  Essence Pharmaceutical Company. It   was explained to the patient that the drug to be rubbed 1-1.5 inch, three times a day, for a period of four weeks on painful site without massage .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain number with Visual Analogue Scale  (VAS). Timepoint: Measurment of pain before intervention and 14 and 30 days after intervention. Method of measurement: Visual Analogue Scale.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-26</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Babol</contact_name>
        <contact_address>No. 6,Sobhan Apartment, 21 Golestan, Eastern Belt, Babol. Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
