<?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>IRCT20240723062520N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-01</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Formulation and clinical assessment of erythropoietin oral gel in treatment of stomatitis caused by chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Formulation and clinical assessment of erythropoietin oral gel in treatment of stomatitis caused by chemotherapy: A double blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78154</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Replacement blocks - 5 blocks with a volume of 10 were prepared with RA software, Blinding description: Patients participating in the research plan and their companions - the student who is the main researcher, data collector and outcome evaluator - the consultant professor and the hospital staff who are the clinical care of the patients - the statistical consultant who analyzes the data .</study_design>
      <phase>3</phase>
      <hc_freetext>oral mucositis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The combined formulation is prepared in the form of 6000 units of erythropoietin in 100 grams of honey (as a gel base), the patient takes a specific amount of the medicine with a special measuring cup and puts it on any part of the mouth that has symptoms (10 grams per day). . - The amount of medicine that reaches the oral mucosa is 60 units per 10 grams of medicine, in this group of patients, they receive routine medicines along with erythropoietin honey gel for 14 days and three times a day. Intervention 2: Control group: patients in this group receive honey gel (placebo), the total amount of placebo is 100 grams. In this group, patients receive routine medications with honey gel for 14 days and three times a day.</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:
Patients' information such as age, gender, type of illness, medications, etc., which are given in the relevant checklist, can be shared.

When:
From 2024

To whom:
Researchers working in academic and pharmaceutical institutions

Conditions:
Researchers working in academic and pharmaceutical institutions

Where to obtain:
Seyedeh Fatemeh Abedi 
sfa1376@gmail.com
st_abedi@skums.ac.ir

How to obtain:
2-3 weeks is the time required to share the information of this study with the document requester.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, 5 Alley, North Mushfegh Kashani Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8179697394</zip>
        <telephone>+98 31 3774 7456</telephone>
        <email>st_abedi@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Fatemeh Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, 5 Alley ,North  Mushfegh Kashani Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8179697394</zip>
        <telephone>+98 31 3774 7456</telephone>
        <email>st_abedi@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who receive chemotherapy for solid tumor or hematology and the treatment regimen is capable of causing mucositis.
Having neutrophils between 1800 and 7700 per cubic millimeter
Being 14 to 60 years old</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an underlying disease of diabetes, kidney disease, liver disease, digestive diseases, allergy, allergic rhinitis, asthma, having an immune system deficiency disease
History of smoking, hookah, tobacco, drugs and alcohol, receiving radiation therapy for one hour
Death or non-cooperation of patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oral mucositis (ulcerative)</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: The combined formulation is prepared in the form of 6000 units of erythropoietin in 100 grams of honey (as a gel base), the patient takes a specific amount of the medicine with a special measuring cup and puts it on any part of the mouth that has symptoms (10 grams per day). . - The amount of medicine that reaches the oral mucosa is 60 units per 10 grams of medicine, in this group of patients, they receive routine medicines along with erythropoietin honey gel for 14 days and three times a day.</i_keyword>
      <i_keyword>Control group: patients in this group receive honey gel (placebo), the total amount of placebo is 100 grams. In this group, patients receive routine medications with honey gel for 14 days and three times a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Age. Timepoint: before starting treatment. Method of measurement: Birth certificate age.</prim_outcome>
      <prim_outcome>Treated groups. Timepoint: before starting treatment. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Erythema and pain. Timepoint: Days 1,7,14. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Erythema and ulcer. Timepoint: Days 1,7,14. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Severe Erythema and ulcer. Timepoint: Days 1,7,14. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Severe stomatitis without the ability to eat. Timepoint: Days 1,7,14. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Type of medicine. Timepoint: Days 1,7,14. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Duration of illness. Timepoint: Days 1,7,14. Method of measurement: observation.</prim_outcome>
      <prim_outcome>The number of neutrophils. Timepoint: After the first course of chemotherapy. Method of measurement: Complete blood count.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-03</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>No. B46 ,5 Alley, North Mushfegh Kashani Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
