<?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>IRCT20180712040446N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Cucumis Melo L seeds on  patients with benign prostatic hypertrophy</public_title>
      <acronym>BPH</acronym>
      <scientific_title>Comparison the effect of Cucumis Melo L seeds oral product and Tamsulosin with Tamsulosin and placebo in reducing the symptoms of patients with benign prostatic hypertrophy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57754</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the balanced block randomization method. Random division is done in the form of "blocks" of predetermined size. For example, if the size of block is 6, the operation of random division until the third one person is randomly assigned to one group, and then individuals are automatically assigned to another group until a 6-piece block is completed. The features of this method are that it is easy to implement and balance in the number of groups is guaranteed, Blinding description: In this study, in addition to the patient, health care personnel, data collectors, and those evaluating the outcome are blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Benign Prostatic Hypertrophy. Condition 2: Lower Urinary Tract Symptoms.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Will received Tamsulosin (0.4 mg per night, 1 piece) with Cucumis melo L seeds 500 mg oral capsule three times daily after each meal for up to 6 weeks. The medicine is made by a pharmacist. Intervention 2: Control group: The control group received Tamsulosin (0.4 mg 1 per night) with placebo oral capsules (500 mg of starch) three times daily after each meal for up to 6 weeks.</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 محرمانه بودن</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Pejman Shadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali-nejad Str., Vanak Sq. Vali-e-asr Boul, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۶۹۷۱۴۷۱۳</zip>
        <telephone>+98 21 81161</telephone>
        <email>pshadpour@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Pejman Shadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hasheminejd Kidney Center, Vali-nejad Str., Vanak Sq. Vali-e-asr Boul, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۶۹۷۱۴۷۱۳</zip>
        <telephone>+98 21 81161</telephone>
        <email>pshadpour@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients aged 45 to 75 years with BPH who include at least one of the following:
International Score of Prostate Symptoms (IPSS) over 13 at the time of screening
PSA higher than 3 ng / ml.
Prostate volume greater than 30 mm detected by ultrasound
Patients who are able and willing to sign a written consent.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Surgery, infection, lower urinary tract disease (bladder stones, neurogenic bladder, bladder malignancy, urethral stricture, hematuria Gross) Diabetes, Heart disease (heart failure, MI, unstable angina), Hepato-renal disease
Use of drugs affecting the bladder and prostate (anticholinergics, sympathomimetics, antidepressants)
Patients who are unable to use oral medication.
Participate in concurrent drug intervention.
Allergy to medicinal plants.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N40.1</hc_code>
      <hc_code>N40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Enlarged prostate with lower urinary tract symptoms</hc_keyword>
      <hc_keyword>Enlarged prostate with lower urinary tract symptoms</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Will received Tamsulosin (0.4 mg per night, 1 piece) with Cucumis melo L seeds 500 mg oral capsule three times daily after each meal for up to 6 weeks. The medicine is made by a pharmacist.</i_keyword>
      <i_keyword>Control group: The control group received Tamsulosin (0.4 mg 1 per night) with placebo oral capsules (500 mg of starch) three times daily after each meal for up to 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>تغییرات امتیاز بین اللملی علائم پروستات. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Q max. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Euroflowmetry.</prim_outcome>
      <prim_outcome>Prostate volume. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Prostate specific antigen (PSA). Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: ELISA test.</sec_outcome>
      <sec_outcome>Drug side effects. Timepoint: During the study and two weeks after the study. Method of measurement: Questionnaire.</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>Health Management Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-04</approval_date>
        <contact_name>Research Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
