<?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>IRCT201105136466N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-11-05</date_registration>
      <primary_sponsor>Research Deputy, Shtraz Dental School</primary_sponsor>
      <public_title>The effect of persica ( herbal oral rinse) on halitosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of persica (herbal oral rinse) on halitosis in patient visiting shiraz dental school-2011</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6901</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral halitosis.</hc_freetext>
      <i_freetext>Intervention 1: Persica herbal mouthwash that is available in pharmacies , as directed by company brochure (15 drops in 15 ml water) by a reputable pharmacies supply and Shiraz In the same glass (marked with X for making doube blind) with a volume of 140 ml for use 7 days (14th round) was poured. Patients taking oral and written instruction was given: -) 2 soup spoon, 2 times a day (morning after breakfast and before bed at night) to gargle for 40 seconds. -) After an hour of eating and drinking mouthwash and mouth wash also be avoided. Then we ask the patient in intervention group to use it and come back for examination in next visit. Intervention 2: Placebo (including water and alcohol and essential oil flavorings without active substance) by a reputable pharmacies supply and Shiraz In the same glass (marked O for making doube blind) with a volume of 140 ml for use 7 days (14th round) was poured. Patients taking oral and written instruction was given: -) 2 soup spoon, 2 times a day (morning after breakfast and before bed at night) to gargle for 40 seconds. -) After an hour of eating and drinking mouthwash and mouth wash also be avoided. Then we ask the patient in control group  to use it and come back for examination in next visit.</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>Dr. Human Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz dental school, Mehr blvd., ghasrodasht st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15878-71956</zip>
        <telephone>+98 71 1626 3193</telephone>
        <email>hebrahimi@sums.ac.ir</email>
        <affiliation>Shiraz Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sara Pourshahidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz dental school, Mehr blvd., ghasrodasht st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15878-71956</zip>
        <telephone>+98 71 1626 3193</telephone>
        <email>purshahidi@sums.ac.ir</email>
        <affiliation>Shiraz Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Participants with organoleptic score &gt; 2 and tongue coating score &gt; 4 Exclusion criteria: smoking; being alcoholic; systemic disease; consumption the medications that cause xerostomia; using antibiotics in previous month; pocket depth &gt;6 mm; eating spicy food or garlic or onion in 48 hours ago and having prosthesis (fix or removable) or orthodontic appliance.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R19.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Halitosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Persica herbal mouthwash that is available in pharmacies , as directed by company brochure (15 drops in 15 ml water) by a reputable pharmacies supply and Shiraz In the same glass (marked with X for making doube blind) with a volume of 140 ml for use 7 days (14th round) was poured. Patients taking oral and written instruction was given: -) 2 soup spoon, 2 times a day (morning after breakfast and before bed at night) to gargle for 40 seconds. -) After an hour of eating and drinking mouthwash and mouth wash also be avoided. Then we ask the patient in intervention group to use it and come back for examination in next visit.</i_keyword>
      <i_keyword>Placebo (including water and alcohol and essential oil flavorings without active substance) by a reputable pharmacies supply and Shiraz In the same glass (marked O for making doube blind) with a volume of 140 ml for use 7 days (14th round) was poured. Patients taking oral and written instruction was given: -) 2 soup spoon, 2 times a day (morning after breakfast and before bed at night) to gargle for 40 seconds. -) After an hour of eating and drinking mouthwash and mouth wash also be avoided. Then we ask the patient in control group  to use it and come back for examination in next visit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral malodor reduction. Timepoint: Before intervention and 7 days after intervention. Method of measurement: Organoleptic score and Winkle tongue coating score.</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>Research Deputy, Shtraz Dental School</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-07-14</approval_date>
        <contact_name>Shiraz Dental School Ethics Committee</contact_name>
        <contact_address>Shiraz dental school, Mehr blvd., ghasrodasht st. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
