<?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>IRCT20200905048627N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-16</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>effect of Anahil Plus and Ibuprofen on pain after root canal treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the analgesic effect of Anahil Plus and ibuprofen on pain after root canal treatment: a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50742</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method is 2-step. In the first step, using a simple random sampling method, samples with inclusion criteria will be selected.
In the second stage, the blocked randomization method will be used for random allocation. Using blocked randomization, samples are assigned to two groups. The blocked randomization process is done with random allocation software. The samples will be placed in thirteen hexagonal blocks as mentioned, Blinding description: Due to the type of medication, there is no possibility of double-blinding, so the person who records the pain score is blinded without knowing the type of medication.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Post endodontic pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Anahil Plus capsules containing 150 mg of bromelain and 300 mg of turmeric, Permon Amin Health Company, single dose before endodontic treatment. Intervention 2: Control group: Ibuprofen 400 mg tablet Saponin company single dose before endodontic treatment.</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 there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Keshvardoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tooba dental clinic, khazar Blv, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816895475</zip>
        <telephone>+98 11 3324 4894</telephone>
        <email>F.keshvardoost@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Narges Hoshyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tooba dental clinic, khazar Blvd, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816895475</zip>
        <telephone>+98 11 3324 4894</telephone>
        <email>narjeshoshyari@rocketmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy patients aged 20 to 50 years
Posterior teeth with irreversible pulpitis
Spontaneous pain with at least 30mm on Visual Analogue Scale
Radiographically normal teeth, without any lesions, without sinus tract and without acute periapical abscess
Normal patients according to the Hospital Anxiety and Depression Scale
Prolonged tooth response to pulp electrical test and Endo-ice test
Fill in and sign the consent form</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking medication that interferes with Non Steroid Anti Inflammatory Drugs or Lidocaine
Existence of systemic disease
Pregnancy or breastfeeding
allergy to pineapple, celery, carrot and fennel
Consumers of anticoagulants
Existence of aggressive periodontal disease
unable to restore the tooth
pain in more than one tooth</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: Anahil Plus capsules containing 150 mg of bromelain and 300 mg of turmeric, Permon Amin Health Company, single dose before endodontic treatment</i_keyword>
      <i_keyword>Control group: Ibuprofen 400 mg tablet Saponin company single dose before endodontic treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain after endodontic treatment. Timepoint: 6, 12 and 24 hours after endodontic treatment. Method of measurement: Visual Analouge Scale questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-06</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Vali-asr Highway, Imam Square, Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
