<?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>IRCT20190701044062N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-13</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Sodium Pentaborate Topical Ointment on Hemorrhoid Symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Sodium Pentaborate Topical Ointment on Hemorrhoid Symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>53</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40539</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Given the fact that the sample size is the same in both groups, we use the Excel software and the formula = Rand () to randomize and to increase the precision and balance of the samples in the randomization (for any reason Patient will withdraw from the plan) we use several blocks per group. It will also be provided to the physician to cover the allocation of matte envelopes, Blinding description: A gel that has an active ingredient in boron 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. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the gel used for the patient may be medication or medication. Clinicians and blind patients will be blinded.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Hemorrhoid.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 3% sodium pentahydrate Phenytoinate gel twice daily for 1 month. Intervention 2: Control group: Treating patients with hemorrhoids in a way other than the mentioned procedure.</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:
A portion of the data will be shared.

When:
2020

To whom:
University researchers and professors

Conditions:
For further studies

Where to obtain:
by Email

How to obtain:
Request via email

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 3335 9680</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>65-18 years old
Patients with hemorrhoids and those with I, II, III or IV internal hemorrhoid disorder without need for emergency interventions based on physical examination
The presence of anal bleeding as one of the symptoms of a hemorrhoid in the patient (according to the Sodergren scoring system)
Non-use of a drug other than the drug and control drug for the treatment of hemorrhoids during the study period</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disorders and analgesics including inflammatory bowel disease, Fisher, fistula and perianal rash, rectal prolapse, rectus, benign or malignant tumor of the anus and rectum, and perianal infections
Patients with sodium phentetrazur susceptibility or a history of skin sensitivity to vaseline
Pregnancy or breastfeeding
Patients with severe heart disease, neurology, liver and kidney disease and blood diseases
Taking any local analgesic for the past 7 days
Prohibition of topical use of vaseline or sodium panteurate
The history of permanent prolapse is the entire thickness of the rectum</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemorrhoids and perianal venous thrombosis</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: 3% sodium pentahydrate Phenytoinate gel twice daily for 1 month</i_keyword>
      <i_keyword>Control group: Treating patients with hemorrhoids in a way other than the mentioned procedure</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severe itching. Timepoint: 25 to 30 days. Method of measurement: questionnaire and Sodergren Scoring System.</prim_outcome>
      <prim_outcome>Severity of pain during rest. Timepoint: 25 to 30 days. Method of measurement: Severity of pain during rest.</prim_outcome>
      <prim_outcome>Pain intensity when starting fecal excretion. Timepoint: 25 to 30 days. Method of measurement: Pain intensity when starting fecal excretion.</prim_outcome>
      <prim_outcome>Frequent feeling of mass in the anus. Timepoint: 25 to 30 days. Method of measurement: Frequent feeling of mass in the anus.</prim_outcome>
      <prim_outcome>The severity of the outgrowth of the hemorrhoid mass. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation.</prim_outcome>
      <prim_outcome>The degree of anoscopic hemorrhoids. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation.</prim_outcome>
      <prim_outcome>Number of hemorrhoid hemorrhages. Timepoint: 25 to 30 days. Method of measurement: Clinical evaluation.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-03</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 -Golghast St.- Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
