<?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>IRCT20130713013976N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-08</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Aloe vera in Adenotonsillectomy pain reduction</public_title>
      <acronym></acronym>
      <scientific_title>Study of the efficacy of aloe vera mouthwash on reduction of post Adenotonsillectomy pain in 5-12 years old children referred to Behesht Hospital of Hamedan in 2019 : three blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>220</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41058</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This activity was performed by a pharmacist colleague.
For this purpose, quadratic block randomization was used. Therefore, four sheets of paper were prepared and written on two letters A (for Aloe vera group) and two other letters N (for normal saline). The sheets were mixed together and placed in a drawer. One of the sheets was randomly drawn out and assigned to one of two groups (aloe vera or normal saline) whether the paper was assigned to as A or N and thus each group of normal saline and aloe vera bottles was randomly numbered from one to one hundred and twenty. It should be noted that the extruded sheets were not returned to the drawer until all four sheets were removed, and after all the four sheets were randomly removed, all the sheets were returned to the drawer again and the above operation was carried out for another four bottles until one hundred. And ten cases from each group continued, Blinding description: In this study, the shape of both bottles (aloe vera and placebo) was identical and was coded by a randomized four-block method. Bottle distributors (researchers), patients and the person performing the statistical analysis were not aware of the nature of the substance in the bottle, and after completing the data analysis and identifying the results, the drug code was decoded and the affect of each drug was identified and recorded.</study_design>
      <phase>3</phase>
      <hc_freetext>Adenotonsillar hypertrophy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The surgical site was washed. Then 10 cc of Aloe vera mouth wash was applied 1 minute before the surgery and the same amount right after surgery. The mouth wash was used 5 cc 3 times a day for 5 days. Intervention 2: Control group: The surgical site was washed. Then 10 cc of normal saline mouth wash was applied 1 minute before the surgery and the same amount right after surgery. The mouth wash was used 5 cc 3 times a day for 5 days.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Hassan Nazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical science, Ayatollah Kashani Blvd, Hamadan, Iran.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+98 921 660 1218</telephone>
        <email>mnazemi1372@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javaneh Jahanshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat hospital, Hamadan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+98 81 3264 0020</telephone>
        <email>J.JAHANSHAHI@UMSHA.AC.IR</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing Adenotonsillectomyک
Age 4 to 12 yearsک
Both sexes</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to Aloe vera
Any known systemic disease, such as congenital anomalies, bleeding disorders, type 1 diabetes, kidney disease, colds, and fever
Using cautery during surgery
No understanding the pain assessment tool (VAS) by the child;
No parental consent</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The surgical site was washed. Then 10 cc of Aloe vera mouth wash was applied 1 minute before the surgery and the same amount right after surgery. The mouth wash was used 5 cc 3 times a day for 5 days.</i_keyword>
      <i_keyword>Control group: The surgical site was washed. Then 10 cc of normal saline mouth wash was applied 1 minute before the surgery and the same amount right after surgery. The mouth wash was used 5 cc 3 times a day for 5 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sore throat. Timepoint: Measurement of sore throat in the first 5 days after Adenotonsillectomy. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The frequency of use of prescribed acetaminophen intake. Timepoint: In the first 5 days after Adenotonsillectomy. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Ear pain (autoelastic). Timepoint: In the first 5 days after Adenotonsillectomy. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Normal diet tolerance. Timepoint: In the first 5 days after Adenotonsillectomy. 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>Barij Essence Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-16</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Science</contact_name>
        <contact_address>Ethics Committee of Hamadan University of Medical Science, Khaje Rashid Blv., Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
