<?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>IRCT20161017030336N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-30</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Botox and Nitroglycerin Ointment on Anal Fissure Repair</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Botox and Nitroglycerin Ointment on Anal Fissure Repair</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46430</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Chronic Anal fissure. Condition 2: Acute anal fissure. Condition 3: Anal fissure, unspecified. Condition 4: Abscess of anal and rectal regions.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (A) will use 0.2% Nitroglycerin or Glycerin Trinitrate ointment made by Caspian Tamin Pharmaceutical Company at the wound site, twice daily for 12 hours for 6 weeks. During this 6-week period, patients will use 3 tubes of ointment. Patients are followed up in the first week, second week, fourth week and sixth month after treatment. Nitroglycerin ointment helps to cure fissile disease by lowering sphincter muscle pressure and increasing blood flow. The most important complication after using this ointment is headache and hypotension. Intervention 2: Intervention group (B) will use Botox ointment at the wound site, twice daily for 12 hours for 6 weeks. During this 6-week period, patients will use three ointment tubes. Follow-up is done in the first week, second week, fourth week and six months after treatment.Botox ointment can help treat this condition. In some cases, it can be injected to relieve pain when using other therapies. This procedure is performed using botulinum toxin to the wound. This toxin causes paralysis of the sphincter muscle for a limited time. This can relieve muscle cramps, or spasm, and relieve the pain of the patient. In addition, this toxin can also help repair the fissure caused by fissures.</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>Dr.Hossein Anari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>h.anari@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Siamak Rakei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>siamakrakei53@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic anal fissure disease</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction.
Having incarcerated wounds.
Pregnancy.
Allergies to the ointments used in this scheme.
Patients who had previously undergone Fischer anal
Patients undergoing Fischer's anal surgery for any reason.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K60.1</hc_code>
      <hc_code>K60.0</hc_code>
      <hc_code>K60.2</hc_code>
      <hc_code>K61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic anal fissure</hc_keyword>
      <hc_keyword>Acute anal fissure</hc_keyword>
      <hc_keyword>Anal fissure, unspecified</hc_keyword>
      <hc_keyword>Abscess of anal and rectal regions</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 (A) will use 0.2% Nitroglycerin or Glycerin Trinitrate ointment made by Caspian Tamin Pharmaceutical Company at the wound site, twice daily for 12 hours for 6 weeks. During this 6-week period, patients will use 3 tubes of ointment. Patients are followed up in the first week, second week, fourth week and sixth month after treatment. Nitroglycerin ointment helps to cure fissile disease by lowering sphincter muscle pressure and increasing blood flow. The most important complication after using this ointment is headache and hypotension.</i_keyword>
      <i_keyword>Intervention group (B) will use Botox ointment at the wound site, twice daily for 12 hours for 6 weeks. During this 6-week period, patients will use three ointment tubes. Follow-up is done in the first week, second week, fourth week and six months after treatment.Botox ointment can help treat this condition. In some cases, it can be injected to relieve pain when using other therapies. This procedure is performed using botulinum toxin to the wound. This toxin causes paralysis of the sphincter muscle for a limited time. This can relieve muscle cramps, or spasm, and relieve the pain of the patient. In addition, this toxin can also help repair the fissure caused by fissures.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammation at the wound site. Timepoint: Before intervention, 7, 14 and 28 days after intervention. Method of measurement: In-person examination.</prim_outcome>
      <prim_outcome>Pain in the wound site. Timepoint: Before intervention, 7, 14 and 28 days after intervention. Method of measurement: Visual Anxiety 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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-02</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Basidj Bridge, Sadasht Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
