<?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>IRCT20200722048172N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison and evaluation of the effectiveness of oral captopril and oral hydrochlorothiazide in the treatment of urgency hypertensive patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison and evaluation of the effectiveness of oral captopril and oral hydrochlorothiazide in the treatment of urgency hypertensive patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49880</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: If the inclusion criteria are met and blood pressure does not decrease after 20 minutes of rest, after randomization of the block and placing patients in two groups A and B in order to eliminate the bias caused by patient awareness and health care (which task The capsule is given to the patient and the measurements and information are recorded from the beginning of the study) depending on the type of treatment received and its possible effect on the results, the study will be performed blindly, so captopril and hydrochlorothiazide tablets in exactly the same capsules They are placed so that the patient and the health care provider are not informed about the type of medicine received, Blinding description: If the inclusion criteria are met and after 20 minutes of rest and taking 2 equal blood presses 5 minutes apart, patients are randomly divided into two equal groups by block randomization. The drug is then given by a special clinical caregiver who is not aware of the type of drug to the study participant who is also not an absolute drug to be swallowed with water in the standard way and then in 10, 20, 30, 45, 60, 90, 120, 180  minutes After administration of the drug, systolic, diastolic blood pressure and heart rate in the sitting physical position will be taken by the same clinical caregiver.</study_design>
      <phase>3</phase>
      <hc_freetext>Urgency Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Taking captopril 25 mg orally and in a single dose. Intervention 2: Intervention group:Take hydrochlorothiazide 25 mg orally and in a single dose.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Razavianzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Al-Anbia Hospital., University Blvd</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614871151</zip>
        <telephone>+98 23 3233 9661</telephone>
        <email>nasrinrazavianzadeh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Nazavianzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Al-Anbia Hospital., University Blvd</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614871151</zip>
        <telephone>+98 23 3233 9661</telephone>
        <email>nasrinrazavianzadeh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with known hypertension with a blood pressure of 160/90 mm Hg or more and patients with the new-onset sever hypertention with a blood pressure of 180/110 mm Hg or more without organ damage (urgency) will be included in the study if satisfied.
Patients between the ages of 18 and 65 will be included in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who need intravenous drugs to control their blood pressure or other blood pressure medications for different reasons.
Patients who need  high dose of ACEIs or ARBs (&gt; 50 mg/d Captopril, &gt; 10 mg/d Enalapril, &gt; 5 g/dLisinopril, &gt; 50 mg/d Losartan, &gt; 80 mg/d Valsartan),to control their blood pressure.
Patients with myocardial infarction presenting with acute chest pain.
Patients with severe renal or hepatic failure,anuria, papillaryedema, pulmonary edema, loss of consciousness, seizure,aortic dissection, or bilateral renal artery stenosis; pregnantpatients, patients with a history of overt allergy or angioedemawith ACEIs, Allergy to penicillins and sulfonamides.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</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:Taking captopril 25 mg orally and in a single dose</i_keyword>
      <i_keyword>Intervention group:Take hydrochlorothiazide 25 mg orally and in a single dose</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic Blood Pressure. Timepoint: In 10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration. Method of measurement: With a hand pressure guage and with ascale of millimeters of mercury.</prim_outcome>
      <prim_outcome>Diastolic Blood Pressure. Timepoint: In 10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration. Method of measurement: With a hand pressure guage and with ascale of millimeters of mercury.</prim_outcome>
      <prim_outcome>Mean Blood Pressure. Timepoint: 10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration. Method of measurement: After measuring systolic and diastolic blood pressure its measured with the sum of  twice the diastolic blood pressure and systolic blood pressure divided by three (3 / (2DBP + SBP)) will be calculated.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: 10, 20, 30, 45, 60, 90, 120, 180 minutes after drug administration. Method of measurement: It will be obtained by counting the number of pulses per minute.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction rate. Timepoint: At intervals and ends of measurements. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Drug side effects. Timepoint: At intervals and ends of measurements. 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>Mohammad Amin Qarehkhani</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-03</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Semnan Branch</contact_name>
        <contact_address>Islamic Azad University of Semnan Complex ,Daneshgahi Town Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
