<?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>IRCT20220423054624N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-25</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Alprazolam on blood pressure control</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of oral captopril in comparison with alprazolam and oral captopril in controlling blood pressure in patients with urgent hypertension.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63360</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Patients are randomly divided into two groups of 47 using random allocation software. An envelope will be prepared according to the number of samples, the code of each treatment group will be placed in the envelope, and each patient will be assigned an envelope in which the treatment group is written, Blinding description: Participant: The use of captopril tablets with Folic acid tablets in one group and the use of captopril tablets and alprazolam tablets in another group that the patient is not aware of based on the same color, and shape, and through the use of drugs.
Statistical Analyzer: The treatment groups will be provided to the statistical analyzer using the code for analysis.</study_design>
      <phase>2</phase>
      <hc_freetext>Essential (primary) hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, patients' blood pressure will be taken and recorded before the drug is administered lying down and the standard method using a mercury sphygmomanometer. Patients are then given a 50 mg captopril tablet and a 0.5 mg alprazolam tablet orally. The drug is prescribed only once at the beginning of the study. The patient will be lying on the bed during the study. In order to check the blood pressure of patients, at 30, 60, 90 and 120 minutes after drug administration (4 times in total), patients' blood pressure is taken and recorded with a mercury sphygmomanometer. Due to the fact that the occurrence of drug side effects is one of the consequences, at 30, 60, 90 and 120 minutes after drug administration, the patient is monitored and the occurrence of side effects is evaluated. Intervention 2: Control group: In the control group, patients' blood pressure will be taken and recorded before the drug is prescribed and the standard method will be taken using a mercury sphygmomanometer. Patients are then given a 50 mg captopril tablet with one folic acid tablet orally. The drug is prescribed only once at the beginning of the study. The patient will be lying on the bed during the study. In order to evaluate the blood pressure status of patients in the control group, in 30, 60, 90 and 120 minutes after drug administration (4 times in total), patients' blood pressure is taken and recorded with a mercury sphygmomanometer. Also, at 30, 60, 90 and 120 minutes after drug administration, the patient is monitored and the occurrence of complications is evaluated.</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:
All collected data will be shared after being unidentified and analysed

When:
By the end of 2023

To whom:
For all scholars

Conditions:
For use in studies

Where to obtain:
Emergency department of Imam Hossein Hospital in Shahroud.
Responsible person is Dr. Mohammad Reza Khorsand.
Postal Code 3614773943
Contact number 09126733459
Imam Hassan Hospital in Shahroud. Emergency department

How to obtain:
dr.mohhamadreza khorsand
Email dr_khorsandmd@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DR. Mohammadreza khorsand Kemachali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 409, Third floor , Medical School, Shahroud University of Medical Science and Health Services, Hafte Tir Square, Shahroud ,Iran</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773943</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>dr_khorsandmd@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammadreza Khorsand Kemachali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 409, Third floor , Medical School, Shahroud University of Medical Science and Health Services, Hafte Tir Square, Shahroud ,Iran</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773943</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>dr_khorsandmd@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Systolic blood pressure over 180 or Diastolic blood pressure over 110
age between 18-80 years old
Ability to understand and sign the conscientious informed consent
No previous Allergy to Captopril or Alprazolam</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Left Acute Heart Failure
Chronic Renal Failure
Cardiovascular disease
History of stroke
History of myocardial infraction
Taking other Benzodiazepines in the last week
Taking Muscle Relaxant drugs such as Baclofen
Taking anti-anxiety drugs from other group such as Buspirone or Zolpidem
Pregnant and Lactating women
Occurring an emergency situation which indicates prescribing other Antihypertensive drug based on the Doctor's diagnosis
Patients who have more than 15 mmHg difference in blood pressure between arms .</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: In the intervention group, patients' blood pressure will be taken and recorded before the drug is administered lying down and the standard method using a mercury sphygmomanometer. Patients are then given a 50 mg captopril tablet and a 0.5 mg alprazolam tablet orally. The drug is prescribed only once at the beginning of the study. The patient will be lying on the bed during the study. In order to check the blood pressure of patients, at 30, 60, 90 and 120 minutes after drug administration (4 times in total), patients' blood pressure is taken and recorded with a mercury sphygmomanometer. Due to the fact that the occurrence of drug side effects is one of the consequences, at 30, 60, 90 and 120 minutes after drug administration, the patient is monitored and the occurrence of side effects is evaluated.</i_keyword>
      <i_keyword>Control group: In the control group, patients' blood pressure will be taken and recorded before the drug is prescribed and the standard method will be taken using a mercury sphygmomanometer. Patients are then given a 50 mg captopril tablet with one folic acid tablet orally. The drug is prescribed only once at the beginning of the study. The patient will be lying on the bed during the study. In order to evaluate the blood pressure status of patients in the control group, in 30, 60, 90 and 120 minutes after drug administration (4 times in total), patients' blood pressure is taken and recorded with a mercury sphygmomanometer. Also, at 30, 60, 90 and 120 minutes after drug administration, the patient is monitored and the occurrence of complications is evaluated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: checking blood pressure at the beginning of the study and then at  30 ,60 , 90 and 120 minutes after the intervention. Method of measurement: using a clinical mercury manometer device for monitoring the blood pressure in a standardized manner in which patient is lying down.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-17</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Room 409, third floor , medical school , Shahroud University of Medical sciences and Health Services, Hafte-Tir Square ,Tehran avenue , Shahroud, Semnan, Iran Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
