<?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>IRCT20200427047226N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-01</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Arnebia euchroma ointment on postoperative pain burning and wound healing in hemorrhoidectomy patients</public_title>
      <acronym>Arnebia euchroma</acronym>
      <scientific_title>The effect of Arnebia euchroma ointment on postoperative pain burning and wound healing in hemorrhoidectomy patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47538</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to two groups of tests and controls. Patient allocation in two intervention groups and control group using Block randomization method and in 16 possible four-block blocks that are regulated in each block of two letters AA, ie Arnebia euchroma intervention and CC letter, ie control. The blocks are then randomly selected using a table of random numbers up to 30 four-block blocks, which are continuously determined to determine the type of intervention (ointment or control) to determine the patient's input number, Blinding description: the type of intervention inside the envelope and the intervention number on it. 120 envelopes are registered so that a 30 gram medicine tube can be placed inside it, which can be used twice a day for up to a week.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemorrhoidectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: ARNEBIA                                                                                     Arnebia euchroma plants and roots were purchased from the Sari plant market in northern Iran in February 2017. This plant was kept in the Faculty of Pharmacy, Mazandaran University of Medical Sciences. A. euchroma root was washed and dried in a preheated oven at 40 درجه C for 8 hours. This ointment is made according to the formula of traditional Iranian medicine. Arnebia euchroma ointment is made up of 10% components (10 g of A. euchroma roots, 20 g of goat fat, 15 g of beef butter, 20 g of glycerin and 35 g of Osirine. The weight ratio of Arnebia euchroma ointment was 10% of the original weight. A. euchroma was eaten in a container and heated with beef butter, goat fat and glycerin at 150-100 برای C for 30 minutes, then the samples were placed inside the autoclave for 18 minutes at 121 اد C. The sample was mixed with Osirine, 0.025 g of methyl paraben and 0.015 g of propylene parabens and rubbed for 5 minutes to form a homogeneous ointment. This product was filled in sterile tubes of 50 g and in Was put clean environment. In order to evaluate the stability and concentration ointment formulations them for 2 weeks at 4, 25 and 40 ° C were maintained.After the surgery, the surgeon rubs and bandages two grams of the ointment arnebia in the area of the operation with gas, and this is done every 12 hours to a week by the applicator. As long as the patient is hospitalized, the patient will be guided by the facilitator, and all patients will be instructed on how to do the same twice a day at home and after discharge. Intervention 2: Control group: ousirin                                                                                            .After the surgery, the surgeon rubs and bandages two grams of the ointment ousirin  in the area of the operation with gas, and this is done every 12 hours to a week by the applicator. As long as the patient is hospitalized, the patient will be guided by the facilitator, and all patients will be instructed on how to do the same twice a day at home and after discharge.</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>memarbashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Besat 4 pelak 31</address>
        <city>ferdows</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9771815917</zip>
        <telephone>+98 56 3272 4978</telephone>
        <email>ehsan.memar1991@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Nasiri Fermi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>103/5000 Sari, Imam Square, Joibar Three Ways, at the beginning of Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences</address>
        <city>sary</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>ebrahim.Nasiri.f@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with grade 3 and 4 internal hemorrhoids
Be at least 20 years old and at most 60 years old</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of heart, liver and kidney disease
No history of alcohol or drug abuse
No history of colorectal surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K62</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of anus and rectum</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: ARNEBIA                                                                                     Arnebia euchroma plants and roots were purchased from the Sari plant market in northern Iran in February 2017. This plant was kept in the Faculty of Pharmacy, Mazandaran University of Medical Sciences. A. euchroma root was washed and dried in a preheated oven at 40 درجه C for 8 hours. This ointment is made according to the formula of traditional Iranian medicine. Arnebia euchroma ointment is made up of 10% components (10 g of A. euchroma roots, 20 g of goat fat, 15 g of beef butter, 20 g of glycerin and 35 g of Osirine. The weight ratio of Arnebia euchroma ointment was 10% of the original weight. A. euchroma was eaten in a container and heated with beef butter, goat fat and glycerin at 150-100 برای C for 30 minutes, then the samples were placed inside the autoclave for 18 minutes at 121 اد C. The sample was mixed with Osirine, 0.025 g of methyl paraben and 0.015 g of propylene parabens and rubbed for 5 minutes to form a homogeneous ointment. This product was filled in sterile tubes of 50 g and in Was put clean environment. In order to evaluate the stability and concentration ointment formulations them for 2 weeks at 4, 25 and 40 ° C were maintained.After the surgery, the surgeon rubs and bandages two grams of the ointment arnebia in the area of the operation with gas, and this is done every 12 hours to a week by the applicator. As long as the patient is hospitalized, the patient will be guided by the facilitator, and all patients will be instructed on how to do the same twice a day at home and after discharge.</i_keyword>
      <i_keyword>Control group: ousirin                                                                                            .After the surgery, the surgeon rubs and bandages two grams of the ointment ousirin  in the area of the operation with gas, and this is done every 12 hours to a week by the applicator. As long as the patient is hospitalized, the patient will be guided by the facilitator, and all patients will be instructed on how to do the same twice a day at home and after discharge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PAIN. Timepoint: After surgery (recovery), 4, 12 and 24 hours after surgery_2 and 4 and 7 days after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Burning. Timepoint: After surgery (recovery), 4, 12 and 24 hours after surgery_2 and 4 and 7 days after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Wound healing. Timepoint: One week after surgery. Method of measurement: Grade 1 and 2 poor repair,  3 and 4 good repair5 excellent repairs.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vomit. Timepoint: Duration of hospitalization. Method of measurement: The number of times.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: Duration of hospitalization. Method of measurement: The number of times.</sec_outcome>
      <sec_outcome>Feeling unwell in the stomach. Timepoint: Duration of hospitalization. Method of measurement: The number of times.</sec_outcome>
      <sec_outcome>Diarrhea. Timepoint: Duration of hospitalization. Method of measurement: The number of times.</sec_outcome>
      <sec_outcome>Defecation. Timepoint: Duration of hospitalization. Method of measurement: The number of times.</sec_outcome>
      <sec_outcome>Urine. Timepoint: Duration of hospitalization. Method of measurement: The number of times.</sec_outcome>
      <sec_outcome>Received housing. Timepoint: Duration of hospitalization. Method of measurement: Type and volume of medication.</sec_outcome>
      <sec_outcome>Headache. Timepoint: Duration of hospitalization. Method of measurement: yes_no.</sec_outcome>
      <sec_outcome>Fear of first defecation. Timepoint: During defecationمعیار آنالوگ بینایی. Method of measurement: (Visual Analogue Scale).</sec_outcome>
      <sec_outcome>Itching. Timepoint: Duration of hospitalization. Method of measurement: (Visual Analogue Scale).</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>2020-04-25</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>39/5000 Teacher Street. Moallem Square Research Deputy sary Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
