<?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>IRCT2015020110326N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-25</date_registration>
      <primary_sponsor>Vice Chancellor for Research &amp; Technology, Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Captophyte compound in comparison with Captopril alone  on blood pressure in patients with essential hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Captophyte compound in comparison with Captopril alone  on blood pressure in patients with essential hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Random number generator table.</study_design>
      <phase>2</phase>
      <hc_freetext>Essential Hypertesion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:  Captophyte compound  divided in two equal 2g doses of red  algae and combined with captopril 25 mg tablets in a capsule  (Captophyte capsule) three times daily for 28 days. Intervention 2: Control group: 25 mg captopril combined with placebo (from DANA pharmaceuticals) is used for 28 days.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyedeh Tasnim Eghbal Eftekhaari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molecular Medicine Research Center, Shahid Mohammdi Hospital, Jomhouri Blvd</address>
        <city>Bandar-e Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>teftekhari@hums.ac.ir; tasnim.eftekhaari@gmail.com</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Abdolazim Nejatizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Research &amp; Technology, Shahid Mohammdi Hospital, Jomhouri Blvd</address>
        <city>Bandar-e Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>anejatizadeh@hums.ac.ir; azimnejate@yahoo.com</email>
        <affiliation>Hormozgan University of Medical Sciences,</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: essential hypertension; age of 20 - 55 years and no response to diet and exercise in prehypertension state.&#13;
 Exclusion criteria: one or more of the following: &#13;
Creatinine levels &gt; 1.5 mg/dl; elevated liver enzymes; intake of any of the anti-hypertensive medications (nitrates, beta blockers, anhydrase carbonic inhibitors, calcium channel blockers, diuretics and angiotensin receptor blocker) due any other underlying medical causes; concurrent intake of any medications having hepatic metabolism (with super enzymes of cytochrome p450 including CYP2D6 (i.e. imipramine, fluoxetine, promethazine, celcoxib, hydroxyzine, citalopram, dextrometorphan, codeine, ondansetron, tamoxifen, tarmadol ). CYP3A4 (clarythromycin, erythromycin, cimetidine, carbamazepine, phenytoin, phenobarbital, rifampin, corticosteroids, atorvastatin, benzodiazepines, and haloperidol) which metabolize most of BB, CCB, ACEI, ARB; medication with warfarin; other cardiovascular complications such as angina pectoris, IHD, hypertensive crisis, or cerebrovascular accidents such as TIA, or stroke which require CCB, BB, ACE; GI disturbances; allergic reactions; immunologic reactions; unwillingness to participate in the study; death of the patient.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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 1:  Captophyte compound  divided in two equal 2g doses of red  algae and combined with captopril 25 mg tablets in a capsule  (Captophyte capsule) three times daily for 28 days.</i_keyword>
      <i_keyword>Control group: 25 mg captopril combined with placebo (from DANA pharmaceuticals) is used for 28 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Every week for 28 days. Method of measurement: Measuring blood pressure with mercury sphygmomannometer.</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>Vice Chancellor for Research &amp; Technology, Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-25</approval_date>
        <contact_name>Hormozgan University Ethics Committee</contact_name>
        <contact_address>Shahid Mohammadi hospital, Department of research &amp; Technology, Ethics Committee Bandar-e Abbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
