<?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>IRCT20200413047059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-09</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparative effect of chlorhexidine mouthwash with plant-based mouthwash in the prevention of pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of chlorhexidine mouthwash with plant-based mouthwash in the prevention of ventilator-related pneumonia in patients admitted to the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simply put, the individual was divided into two groups of 40 by referring to the hospital and the relevant department and using the SPSS statistical software version 23, Blinding description: In order to observe blindness, the study of patients and the person who determines the final result of the study (the patient's doctor) will not be aware of the groups under study and the study will be of the blind type.</study_design>
      <phase>2</phase>
      <hc_freetext>Ventilate-related pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, treatment with chlorhexidine is 0.2%. The frequency, timing, and manner of mouth washing in this group will be performed in the same way, three times a day for 5 days, every eight hours. First, a sterile gauze wrap is wrapped around an abscess and then soaked in a mouthwash, and like a toothbrush, all areas of the mouth, gums, tongue, throat, and teeth are washed for 6 minutes. The amount of chlorination in each wash is 10 cc and in the case of butter, the consumption of 25-20 drops per half cup of water is dissolved. Intervention 2: Intervention group: Dine mouthwash made by Dineh Pharmaceutical Company. In the second group, treatment will begin with a mouthwash. Frequency, timing, and method of mouth washing in both groups will be done in the same way and three times a day for 5 days, every eight hours. First, a sterile gauze wrapped around a tongue blade and then soaked in mouthwash, and like a toothbrush, all areas of the mouth, gums, tongue, throat, and teeth are washed for 6 minutes. The amount of chlorination in each wash is 10 cc and in the case of butter, the consumption of 25-20 drops per half cup of water is dissolved.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
A part of the data such as information about the main consequence

When:
Starting access in the fall of 2020

To whom:
Researchers

Conditions:
In case of further studies and changes in different doses and materials, the use of documents is allowed.

Where to obtain:
Submit a request by e-mail to the author and provide a title related to the study

How to obtain:
The request will be sent by e-mail and the documents will be sent one week after the review.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yeganeh Fatemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St, Isfahan university of medical sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 5550 0111</telephone>
        <email>ygn.ftm1994@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yeganeh Fatemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St, Isfahan university of medical sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 5550 0111</telephone>
        <email>ygn.ftm1994@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Requires mechanical ventilation for at least 48 hours
Do not use the chip pipe before entering the intensive care unit
No specific lesions in and around the mouth
Lack of safety defects
Do not take antibiotics before hospitalization
No pregnancy
Lack of allergy to plant compounds
Has natural teeth
Free and informed written consent of the patient's companion or guardian to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95.851</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ventilator associated pneumonia</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: First, treatment with chlorhexidine is 0.2%. The frequency, timing, and manner of mouth washing in this group will be performed in the same way, three times a day for 5 days, every eight hours. First, a sterile gauze wrap is wrapped around an abscess and then soaked in a mouthwash, and like a toothbrush, all areas of the mouth, gums, tongue, throat, and teeth are washed for 6 minutes. The amount of chlorination in each wash is 10 cc and in the case of butter, the consumption of 25-20 drops per half cup of water is dissolved.</i_keyword>
      <i_keyword>Intervention group: Dine mouthwash made by Dineh Pharmaceutical Company. In the second group, treatment will begin with a mouthwash. Frequency, timing, and method of mouth washing in both groups will be done in the same way and three times a day for 5 days, every eight hours. First, a sterile gauze wrapped around a tongue blade and then soaked in mouthwash, and like a toothbrush, all areas of the mouth, gums, tongue, throat, and teeth are washed for 6 minutes. The amount of chlorination in each wash is 10 cc and in the case of butter, the consumption of 25-20 drops per half cup of water is dissolved.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ventilator-related pneumonia. Timepoint: At the beginning of the study and 3 weeks after using two mouthwashes. Method of measurement: A microbial infection of the lung that occurs more than 48 hours after mechanical ventilation with a ventilator. Diagnosis of this type of pneumonia is based on the symptoms of pulmonary infection (including: purulent discharge, fever and leukocytosis), bacteriological evidence of pulmonary infection, and evidence of lung infection on specific radiographic images.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-07</approval_date>
        <contact_name>National Committee for Ethics in Biomedical Research</contact_name>
        <contact_address>Hezar Jarib St. Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
