<?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>IRCT20220122053783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-20</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Persian honeylocust ointment in  hemorrhoids</public_title>
      <acronym></acronym>
      <scientific_title>Evalution of the effect of ointment containing extract of Persian honeylocust(GleditsiaCaspica) on clinical symptoms and quality of life in patients with hemorrhoids: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61412</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to the intervention and control groups in a block method. The samples will be determined by random blocking method with 2 blocks and using the table of random numbers obtained from Random Allocation Software.  Blocking and allocation sequencing for concealment will be done by the person not involved in the research (Allocation Concealment). The sample allocation ratio will be 1:1 (Allocation 1: 1) and will be placed in two groups receiving ointment containing herbal  extract or placebo ointment (Assignment). Then, the ointments will be delivered to the participants based on the obtained blocks and in the order of allocation, Blinding description: Participants,  the main researchers of the study, the physician, the data collector, and the outcome assessor will be kept blind. The ointments are packed in the same shape tubes and numbered from one to 60 and finally are delivered to the participants in order.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hemorrhoid.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: they will receive an ointment containing hydroalcoholic extract of Persian honeylocust (Gleditsia Caspica) 1 gram/two times a day using an applicator for 2 weeks. Ointments were prepared in Shafa Pajohan Sabz Company, Tabriz, Iran. Intervention 2: Control group: Intervention group: they will receive an ointment containing eucerine 1 gram/two times a day using an applicator for 2 weeks. Ointments were prepared in Shafa Pajohan Sabz Company, Tabriz, Iran.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezoo Moini Jazani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah st. Ardabil Complex Univesity</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۶۱۸۹-۸۵۹۹۱</zip>
        <telephone>+98 45 3353 4790</telephone>
        <email>dr.moeeni@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mirsalim Seyed Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sarein Station, Imam Khomeini St., not far from Shariati Square, Dr. Fatemi Hospital</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3323 2520</telephone>
        <email>salim.seyedsadeghi95@gmail.com</email>
        <affiliation>Ardabil 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 with grade 1-2 internal hemorrhoids
Age 18-65 years
Patients with bleeding or hemorrhoidal prolapse or pain or two or all together
Have a signed informed consent form to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Anorectal diseases such as rectal prolapse, Fisher, fistula, perianal abscess
Thrombosis and gangrenous hemorrhoids
Uncontrolled cardiovascular disease
Cirrhosis
Inflammatory bowel disease (IBD)
Pregnancy and lactation
History of allergy to herbal medicines
Use analgesics less than a week ago
Use of anticoagulants less than a month ago
Use of steroid less than a month ago
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K64.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other hemorrhoids</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: they will receive an ointment containing hydroalcoholic extract of Persian honeylocust (Gleditsia Caspica) 1 gram/two times a day using an applicator for 2 weeks. Ointments were prepared in Shafa Pajohan Sabz Company, Tabriz, Iran.</i_keyword>
      <i_keyword>Control group: Intervention group: they will receive an ointment containing eucerine 1 gram/two times a day using an applicator for 2 weeks. Ointments were prepared in Shafa Pajohan Sabz Company, Tabriz, Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain according to CORECTS questionnaire. Timepoint: At the first (before starting the study), end of the first and the second week. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire.</prim_outcome>
      <prim_outcome>Rectorrhagia according to CORECTS questionnaire. Timepoint: At the fist (before starting the study), end of the first and the second week. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Itching according to CORECTS questionnaire. Timepoint: At the fist (before starting the study), end of the first and the second week. Method of measurement: Colo-Rectal Evaluation of Clinical Therapeutics Scale (CORECTS) questionnaire.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: At the fist (before starting the study), end of the first and the second week. Method of measurement: The World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) questionnaire.</sec_outcome>
      <sec_outcome>Possible side effects of treatment. Timepoint: At the fist (before starting the study), end of the first and the second week. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Satisfaction of treatment. Timepoint: At the fist (before starting the study), end of the first and the second week. Method of measurement: Researcher-made questionnaire (according to 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>Shafa pajohan sabz Company, Tabriz, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-29</approval_date>
        <contact_name>Ethics committee ofArdabil University of Medical Sciences</contact_name>
        <contact_address>Daneshgah st,  Ardabil Complex Univesity Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
