<?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>IRCT20190608043840N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-22</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the efficacy of Maa-al-shaeer (product based on barley seeds) on  radiotherapy induced dysuria</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of efficacy of Maa-al-shaeer (An Iranian medicine product based on barley seeds) in preventing and reducing the severity of radiotherapy-induced dysuria in prostate cancer patients; a double-blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59594</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple Randomization.  Randomization is done using R software version 4.1.2, and we will use the randomization list generated using R software.

In order to conduct this study, first, using the available method, patients who meet the conditions for entering the study, after completing the consent form, will enter the study until the number of calculated samples is complete.  In the next step, in order to homogenize and control the background and confounding variables in the intervention and control groups, the block randomization method will be used to assign patients to two groups.
 For this purpose and according to the calculated sample size, 5 blocks of 14 blocks will be generated using R software.  In each block, the interventions are randomly assigned to people with a ratio of 1:1.
Since the shape of the drug and the placebo are completely similar and the labels on the cans of the interventions (drug or placebo) are prepared by a statistician (using R software) and sticked in the pharmaceutical laboratory, so, the participants and the researcher are all blind to it, Blinding description: Double Blind. In this study, the barley product is prepared in the form of powder and is packed in a can and coded after putting a label. Placebo is also prepared with the same particle size and color as the drug in the same packaging as the drug and is coded. Therefore, until the encoding, it is not possible for the participants, principle investigator, healthcare providers, data collectors, outcome assessors, manuscript writers to distinguish the drug from the placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Prostate Cancer, Radiotherapy-induced dysuria, Urogenital radiotherapy complications.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Twice a day, every 12 hours, one measure of "Maa-al-shaeer" (malted barley powder which was prepared by the school of Traditional Medicine of Shahid Beheshti University of Medical Sciences) is dissolved in a glass of lukewarm water and consumed after meals. Each measure of powder is equivalent to 7.5 cc of powder and the intervention period is four weeks from the start of radiation therapy and the follow-up period is four weeks (without intervention). Intervention 2: Control group: Twice a day, every 12 hours, one measure of placebo powder (which was prepared by the school of Traditional Medicine of Shahid Beheshti University of Medical Sciences) is dissolved in a glass of lukewarm water and consumed after meals. Each measure of powder is equivalent to 7.5 cc of powder and the intervention period is four weeks from the start of radiation therapy and the follow-up period is four weeks (without intervention).</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 The study has not yet started, after the study is completed a decision will be made about sharing the participants' non-identifiable personal data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vida Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine, Shajid Beheshti University of Medical Sciences, No. 8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>vidanazary@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vida Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516745811</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>vidanazary@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over 18 years old
Prostate cancer
Candidate for radiation therapy (at the Radiotherapy Center of Shohada-e-Tajrish Hospital)
Consciousness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unconsciousness or unable to report dysuria
Urinary catheter
Urinary tract infection
Diabetes Mellitus
Dysuria
A history of drug sensitivity
Metastasis
Chemotherapy at the same time
Hematuria
Severe Cardiovascular, Pulmonary, Hepatic and Kidney diseases that need some medical treatments
Not participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Malignant </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>C61</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Twice a day, every 12 hours, one measure of "Maa-al-shaeer" (malted barley powder which was prepared by the school of Traditional Medicine of Shahid Beheshti University of Medical Sciences) is dissolved in a glass of lukewarm water and consumed after meals. Each measure of powder is equivalent to 7.5 cc of powder and the intervention period is four weeks from the start of radiation therapy and the follow-up period is four weeks (without intervention).</i_keyword>
      <i_keyword>Control group: Twice a day, every 12 hours, one measure of placebo powder (which was prepared by the school of Traditional Medicine of Shahid Beheshti University of Medical Sciences) is dissolved in a glass of lukewarm water and consumed after meals. Each measure of powder is equivalent to 7.5 cc of powder and the intervention period is four weeks from the start of radiation therapy and the follow-up period is four weeks (without intervention).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dysuria. Timepoint: Before intervention and 2, 4, 6, 8 weeks after intervention. Method of measurement: IPSS (International prostate symptom score) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Quality of life score before the intervention (week 0) 4 and 8 weeks after the intervention. Method of measurement: EORTC QLQ-PR25 Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Prostate Cancer).</sec_outcome>
      <sec_outcome>The number of phenazopyridine tablets which was used. Timepoint: 2, 4, 6 and 8 weeks after the intervention. Method of measurement: Asking the participants.</sec_outcome>
      <sec_outcome>Treatment satisfaction. Timepoint: 8 weeks after the intervention. Method of measurement: It is measured by asking 1 Likert scale question (very high, high, medium, low and very low).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-12</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Sh. Aarabi Ave., Yaman Ave., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
