<?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>IRCT20190128042525N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-02</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure: a randomized, double-blind clinical trial study</public_title>
      <acronym></acronym>
      <scientific_title>The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure: a randomized, double-blind clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>146</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45759</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups (group one and two) using random numbers' table (simple randomization method), Blinding description: This is a double-blind study. The drugs will be placed in the same and encoded cans, so the patient, doctor and outcome assessor will not be informed about type of prescribed drug. Coding won't be done by principal investigator and won't have access to the coding informations.</study_design>
      <phase>3</phase>
      <hc_freetext>chronic anal fissure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 100 g container contained Glyceryl trinitrate 0.2% -Ostrich oil 50% ointment will be prescribed for the patients. These drugs will be manufactured by Pasargad Rafsanjan Pharmacy. For their formulation 60 ml ostrich oil containers from Iranian cooperative Kesht Va Sanat Misagh, Kesht Ati company under the brand name Mika will be purchased. After making drugs patients will apply approximately 2 cm of it, topically on the anal area every 12 hours. The maximum treatment period will be 12 weeks. Intervention 2: Control group: 100 g container concluded 0.2% Glyceryl trinitrate ointment will be prescribed. approximately 2 cm of it will be applied topically on the anal area every 12 hours. The maximum treatment period will be 12 weeks. The container ingredients will be produced by Pasargad Pharmacy in Rafsanjan.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ibn Abi-Talib Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717937555</zip>
        <telephone>+98 34 3428 0185</telephone>
        <email>clinical.research@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ibn Abi-Talib Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717937555</zip>
        <telephone>+98 34 3428 0185</telephone>
        <email>clinical.research@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with symptoms of the disease such as pain or bleeding during defecation  which was lasting for at least 8 weeks.
Patients having anorectal region's posterior or anterior wound in examination in lithotomy position, which is associated with skin tag. Also horizontal smooth muscle fibers are visible at the base of the wound and sphincter is hypertrophic.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>79 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with other anorectal diseases such as hemorrhoids, fistulas and abscesses, diabetes, tuberculosis, Crohn's and ulcerative colitis, anorectal neoplasm, leukemia and STDs such as AIDS and syphilis.
Patients with history of anal surgery
Patients with history of medical treatment of chronic anal fissure
Patients who underwent pelvic radiotherapy
Patients who are receiving chemotherapy or using immunosuppressive drugs
Patients with anal incontinence
Patients without medical treatment compliance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K60.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic anal fissure</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: 100 g container contained Glyceryl trinitrate 0.2% -Ostrich oil 50% ointment will be prescribed for the patients. These drugs will be manufactured by Pasargad Rafsanjan Pharmacy. For their formulation 60 ml ostrich oil containers from Iranian cooperative Kesht Va Sanat Misagh, Kesht Ati company under the brand name Mika will be purchased. After making drugs patients will apply approximately 2 cm of it, topically on the anal area every 12 hours. The maximum treatment period will be 12 weeks.</i_keyword>
      <i_keyword>Control group: 100 g container concluded 0.2% Glyceryl trinitrate ointment will be prescribed. approximately 2 cm of it will be applied topically on the anal area every 12 hours. The maximum treatment period will be 12 weeks. The container ingredients will be produced by Pasargad Pharmacy in Rafsanjan.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain scoring. Timepoint: Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th &amp; 16th weeks after intervention. Method of measurement: Visual Analogue Scale Questionnaire.</prim_outcome>
      <prim_outcome>Wound grading. Timepoint: Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th &amp; 16th weeks after intervention. Method of measurement: By means of physical examination and grading: grade I (fresh wound with inflammation), grade II (wound with granulation tissue) and grade III (wound covered with complete epithelial tissue).</prim_outcome>
      <prim_outcome>Bleeding grading. Timepoint: Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th &amp; 16th weeks after intervention. Method of measurement: By means of history taking : grade I (there is no bleeding during defecation), grade II (sometimes there is bleeding during defecation) and grade III (there is always bleeding during defecation).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: After complete recovery of the patient and cessation of treatment. Method of measurement: Completing the World Health Organization's (26-Question) Quality of Life Questionnaire.</sec_outcome>
      <sec_outcome>Recurrence of the disease. Timepoint: At the end of 8th &amp; 16th weeks of follow up period. Method of measurement: By history taking and physical examination.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-04</approval_date>
        <contact_name>Ethics committee of rafsanjan University of Medical Sciences</contact_name>
        <contact_address>َAli Ibn Abi-talib Square Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
