<?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>IRCT20190701044062N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of ANSIL in the treatment of anal fissures</public_title>
      <acronym></acronym>
      <scientific_title>comparing the effect of the Ansil gel with placebo on the treatment of acute  Anal fissure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50702</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in a simple way and using Graphpad software.
Each group will be given the numbers A and B and The software will then generate random codes and based on those codes, patients will be provided with the desired drugs, Blinding description: A gel that has an active ingredient in silver nitrate with a gel that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable.  The important point is that the patient is told that the gel used for the patient may be medication or medication.</study_design>
      <phase>2</phase>
      <hc_freetext>acute Anal fissure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:0/2% َAnsil gel (Silver Nitrate) which is made using the nanoparticle mechanism at Tabriz University of Iran and is applied to the wound for two weeks, twice a day in the size of a fingertip. The patient is taught for 15 to 30 minutes by an experienced and trained expert. Intervention 2: Control group: These are the group that take placebo Gel that has no therapeutic properties. It is worth mentioning that the participants in this project are patients with acute anal fissure that placebo was used for this group. We remind you that according to the inclusion criteria, patients should not have used any topical anal drug for at least the last 7 days.</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:
Part of the data, which includes information about the main outcome and results, will be shared.

When:
5 months after printing the results

To whom:
Researchers working in academic institutions

Conditions:
The data will be available to researchers and university professors for the studies of the meta - analysis

Where to obtain:
Email: mh.hejazad@gmail.com

How to obtain:
Request via email: mh.hejazad@gmail.com  As soon as possible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Manouchehr Khoshbaten</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166/15731</zip>
        <telephone>+98 41 3337 2088</telephone>
        <email>mkhoshbaten@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manouchehr Khoshbaten</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166/15731</zip>
        <telephone>+98 41 1334 3010</telephone>
        <email>mkhoshbaten@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 65 years old
cases with Anal fissure symptoms and diagnosis of Anal fissure whithout emergency interventions based on physical examination
Do not use any drug other than the drug under study and the placebo for treatment of Anal fissure during the study period</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>chronic Anal fissure
lateral fissure
the period of pregnancy or breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K60.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute anal fissure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:0/2% َAnsil gel (Silver Nitrate) which is made using the nanoparticle mechanism at Tabriz University of Iran and is applied to the wound for two weeks, twice a day in the size of a fingertip. The patient is taught for 15 to 30 minutes by an experienced and trained expert.</i_keyword>
      <i_keyword>Control group: These are the group that take placebo Gel that has no therapeutic properties. It is worth mentioning that the participants in this project are patients with acute anal fissure that placebo was used for this group. We remind you that according to the inclusion criteria, patients should not have used any topical anal drug for at least the last 7 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anal Fissure healing. Timepoint: at baseline and 2 week after the intervention. Method of measurement: physical examination and health history.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anal itching. Timepoint: at baseline and 2 week after the intervention. Method of measurement: health history.</sec_outcome>
      <sec_outcome>Anal bleeding. Timepoint: at baseline and 2 week after the intervention. Method of measurement: health history.</sec_outcome>
      <sec_outcome>Anal pain at rest. Timepoint: at baseline and 2 week after the intervention. Method of measurement: شرح حال گیری.</sec_outcome>
      <sec_outcome>Anal pain during defecation. Timepoint: at baseline and 2 week after the intervention. Method of measurement: health history.</sec_outcome>
      <sec_outcome>Pulse sensation after defecation. Timepoint: at baseline and 2 week after the intervention. Method of measurement: health history.</sec_outcome>
      <sec_outcome>Feeling of a mass around the anus. Timepoint: at baseline and 2 week after the intervention. Method of measurement: health history.</sec_outcome>
      <sec_outcome>Bleeding of the fissure during the examination. Timepoint: at baseline and 2 week after the intervention. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Pain at the Fissure site during the examination. Timepoint: at baseline and 2 week after the intervention. Method of measurement: 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-18</approval_date>
        <contact_name>ethics committee of Tabriz university of medical sciences</contact_name>
        <contact_address>central office of tabriz university of medical sciences Tabriz,Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
