<?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>IRCT2017060434328N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-14</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Rosemary in decreasing of pain in patients with backache</public_title>
      <acronym></acronym>
      <scientific_title>clinical trial comparison effect of rosemary and  placebo on decreasing pain of acute law back patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26253</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Back ache.</hc_freetext>
      <i_freetext>Intervention 1: Sampling method includes patients who are not allergic to rosemary ointment and do not have any skin deficiency on their waist as well, twenty- four hours before the surgery.They also should be males and willing in order to participate in the study. The patients will be chosen randomly along with single blind method and then they will included in the experimental group by chance respectively. In order to decrease the intervention factors the patients will be chosen homogeneously so that they will benefit all the cures evenly.At first the pain of the patients in the experimental group will be measured and recorded by VAS, then the rosemary ointment for the patients of this group is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total. Intervention 2: In the control group first the pain of the patients will be measured and recorded by VAS Simultaneously, then (Vaseline) the placebo is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ruhollah Mahdiun</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mobasher Kashani dormitary, Mahdiyeh ST., Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516735537</zip>
        <telephone>+98 81 3838 0447</telephone>
        <email>r.mahdiun68@gmail.com; r.mahdiun@edu.umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ruhollah Mahdiun</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mobasher Kashani dormitary, Mahdiyeh ST., Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516735537</zip>
        <telephone>008981338380447</telephone>
        <email>r.mahdiun68@gmail.com; r.mahdiun69@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients who have acute backache and do not have any information about the effects of rosemary; become fully conscious  and be able to analyze pain based on Visual Analog Scale(VAS) and do not have any skin deficiency in pain place as well; patients who are males. Exclusion criteria: patients who experience consciousness reduction during the research; disinclination of chosen patient about cooperation with the researcher; patient's allergy to rosemary ointment.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5 Low </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute low back pain diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Sampling method includes patients who are not allergic to rosemary ointment and do not have any skin deficiency on their waist as well, twenty- four hours before the surgery.They also should be males and willing in order to participate in the study. The patients will be chosen randomly along with single blind method and then they will included in the experimental group by chance respectively. In order to decrease the intervention factors the patients will be chosen homogeneously so that they will benefit all the cures evenly.At first the pain of the patients in the experimental group will be measured and recorded by VAS, then the rosemary ointment for the patients of this group is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total.</i_keyword>
      <i_keyword>In the control group first the pain of the patients will be measured and recorded by VAS Simultaneously, then (Vaseline) the placebo is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain patients. Timepoint: Before the intervention and after the intervention for 6 times at an interval of every half an hour. 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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-02</approval_date>
        <contact_name>Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamedan University of Medical Sciences, across from Mellat park, after Pajohesh sq. Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
