<?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>IRCT20150511022218N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-19</date_registration>
      <primary_sponsor>Neyshabour University of Medical Sciences</primary_sponsor>
      <public_title>The effect of honey lemon solution on postoperative sore throat</public_title>
      <acronym></acronym>
      <scientific_title>The effect of honey lemon solution on the improvement of sore throat after intubation among candidates for general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32613</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, sampling is easy and accessible . patients are randomly dividing into intervention and control groups. It should be noted that the study samples are randomly divided into two groups through block randomization, Blinding description: This study is a single blind clinical trial in which the Nurse that helps researchers to fill out the questionnaire won't know the group patients are belong to.</study_design>
      <phase>3</phase>
      <hc_freetext>postoperative sore throat.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group one hour after surgery and before intervention questionnaires about sore throat, cough and hoarseness will be completed. Then, after 6 hours of surgery, the patient will receive 30 cc of lemon juice and honey. The reconstituted solution will be provided to patients with clear containers. Prescribed solution will also be given to the patients 2 and 4 hours after the first dose. In general, each patient will use the solution mentioned 3 times. The Honey was produced by Khomein Company with a health license number 15/11066. The lemon juice was produced by the Yek&amp;Yek company with a health license number 36/10374. Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed again. Intervention 2: Control group:  In the Control group one hour after surgery questionnaires about sore throat, cough and hoarseness will be completed. In the control group, patients at the same time with the intervention group will use saline as placebo. Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed again.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Aryaeefar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyshabur University of Medical Sciences</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6623451124</zip>
        <telephone>+98 51 4334 4711</telephone>
        <email>m.aryaee2012@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Aryaeefar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyshabur University of Medical Sciences</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6623451124</zip>
        <telephone>+98 51 4334 4711</telephone>
        <email>m.aryaee2012@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Consent form
Surgeon satisfaction for patient ti drink honey and lemon juice solution
Candidate for general anesthesia and endotracheal intubation
The operating time less than 6 hours
Age between 15 to 60 years old
Ability to communicate and answer the questions</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being allergic to honey and lemon juice solution
Having diabetes</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>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group one hour after surgery and before intervention questionnaires about sore throat, cough and hoarseness will be completed. Then, after 6 hours of surgery, the patient will receive 30 cc of lemon juice and honey. The reconstituted solution will be provided to patients with clear containers. Prescribed solution will also be given to the patients 2 and 4 hours after the first dose. In general, each patient will use the solution mentioned 3 times. The Honey was produced by Khomein Company with a health license number 15/11066. The lemon juice was produced by the Yek&amp;Yek company with a health license number 36/10374. Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed again.</i_keyword>
      <i_keyword>Control group:  In the Control group one hour after surgery questionnaires about sore throat, cough and hoarseness will be completed. In the control group, patients at the same time with the intervention group will use saline as placebo. Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sore throat. Timepoint: One hour after surgery and before intervention, 12 and 24 hour after intervention. Method of measurement: Visual Analogue Scale( VAS ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cough. Timepoint: One hour after surgery and before intervention, 12 and 24 hour after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Hoarseness. Timepoint: One hour after surgery and before intervention, 12 and 24 hour after intervention. Method of measurement: questionnaire.</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>Neyshabour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-14</approval_date>
        <contact_name>Ethics Committee of Neyshabur University of Medical Sciences</contact_name>
        <contact_address>Neyshabur University of Medical Sciences Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
