<?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>IRCT20181204041844N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-02</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>evaluation the effect of henna mouthwash on oral lichen planus</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of  Chlorhexidine gluconate 0.2%  mouthwash with  Henna mouthwash as adjuvant therapy on oral lichen planus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by the Randlist software and each patient will be entered in the treatment or control group, Blinding description: Randomization and allocation will be concealed from the researcher and participants until the final analyses are completed. The researcher at the Kerman dental school, who is not aware of random sequences, will deliver the participants to 250cc opaque glass containers that have a similar appearance and contain a mouthwash.The taste and smell of henna and chlorhexidine mouthwashes are similar due to its 2% ethanol content.</study_design>
      <phase>3</phase>
      <hc_freetext>"oral lichen planus".</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Mouthwash 2% of the aqueous extract of Henna plant in the presence of other mouthwash compounds containing 0.1% w / w of methyl parahydroxybenzoate, 2% ethanol, 10% glycerol, distilled water twice a day (morning and evening) and each time  5 ml of the mouthwash for 30 seconds should be used.Gargle with betamethasone lotion four times a day (after meals and at bedtime) for one minute. Intervention 2: Control group: 0.2% chlorhexidine gluconate mouthwash and Iranian betamethasone lotion available on the market twice a day (morning and evening) and each time  5 ml of the mouthwash for 30 seconds should be used.Gargle with betamethasone lotion four times a day (after meals and at bedtime) for one minute.</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:
all collected  deidentified IPD. IPD collected for primary outcome measure only.

When:
6 months after publication

To whom:
it will be available for people working in academic institutions.

Conditions:
people working in academic institutions

Where to obtain:
sov.karbasi@gmail.com dr.nahid.karbasi

How to obtain:
request containing how the data will be used must be applied via email. citation in future publication is mandatory. data will be sent within 3 months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Karbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman,Islamic Republic Boulevard,End of Shafa Street,Kerman Dental School</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>sov.karbasi@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Karbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman,Islamic Republic Boulevard,End of Shafa Street,Kerman Dental School</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 9021</telephone>
        <email>sov.karbasi@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of atrophic and/or erosive lesions of the oral mucosa
Painful lesions
Histological confirmation of the diagnosis of oral lichen</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>presence of dysplasia in the histopathological study of OLP
patients on long-term corticosteroid therapy
the use of drugs capable of inducing lichenoid reactions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lichen planus</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:Mouthwash 2% of the aqueous extract of Henna plant in the presence of other mouthwash compounds containing 0.1% w / w of methyl parahydroxybenzoate, 2% ethanol, 10% glycerol, distilled water twice a day (morning and evening) and each time  5 ml of the mouthwash for 30 seconds should be used.Gargle with betamethasone lotion four times a day (after meals and at bedtime) for one minute.</i_keyword>
      <i_keyword>Control group: 0.2% chlorhexidine gluconate mouthwash and Iranian betamethasone lotion available on the market twice a day (morning and evening) and each time  5 ml of the mouthwash for 30 seconds should be used.Gargle with betamethasone lotion four times a day (after meals and at bedtime) for one minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: before intervention and 7,14 days after intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Clinical presentation or inflammation. Timepoint: before intervention and 7,14 days after intervention. Method of measurement: Thongprasom sign Scoring.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2639-09-19</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman, the center of seven Alavi Gardens, Campus of Kerman University of Medical Sciences kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
