<?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>IRCT20181210041912N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-14</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effects of Donepezil, Galantamine,Rivastigmine and Memantine on vascular dementia.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of Donepezil, Galantamine,Rivastigmine and Memantine on transcranial Doppler sonography  and MMSE   in patients with vascular dementia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35813</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 44 patients with vascular dementia referring to a neurologist were randomly divided into 4 groups of 11 patients. The randomization method is simple and How to create a  sequence. is random, Blinding description: This study was carried out for patients with vascular dementia at the onset of ultrasound and MMSE intervention and then referred to one of the contributors who are unaware of the type of medication.
After receiving the code, the patient is treated with one of the medications in the uncertain packing (A, B, C, D) until the end of the intervention, which is repeated in the above procedures.</study_design>
      <phase>2</phase>
      <hc_freetext>Vascular Dementia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Donpezil starts at 5mg / day and increases to 10mg / day within two weeks and lasts up to three months. Intervention 2: Intervention group:  Rivastigmine starts at 1.5mg twice daily and increases to 3mg twice a week within a week. Intervention 3: Intervention group:  Memantine starts at 5mg daily and increases to 10mg per day in one week. Intervention 4: Intervention group:  Galanthambon is given 8mg daily.</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:
The results of transcranial doppler sonography that shares all the data after unidentifiable individuals.

When:
After completing the transcranial doppler sonography

To whom:
Faculty Members of Medical Universities across Iran

Conditions:
With written request for reuse of files

Where to obtain:
Postcode: Kerman, Kowsar Blvd, Shafa Hospital, Ali Farzan Moghadam
Email:alifarzan57@yahoo.com
phone number:09132512862

How to obtain:
The written and formal request of the applicant who has been approved by the research assistant at the university of the applicant's workplace will be sent no later than one week later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farhad Iranmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Hospital, Kosar Blvd, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۵۱۱۵۱</zip>
        <telephone>+98 34 3211 5780</telephone>
        <email>fpp_farhad@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kave Shafiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Hospital, Kosar Blvd,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۵۱۱۵۱</zip>
        <telephone>+98 34 3211 5780</telephone>
        <email>kshafiee@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with vascular dementia in Kerman city</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any underlying condition other than diabetes, hypertension, hyperlipidemia, and ischemic heart disease, including history of depression and memory and speech impairment.
Use of any medication, such as sedative medicines and substance abuse, except medicines for controlling diabetes, hypertension, hyperlipidemia, and ischemic heart disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>occlusion and stenosis of cerebral and precerebral arteries (including truncus brachiocephalicus), resulting in cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Donpezil starts at 5mg / day and increases to 10mg / day within two weeks and lasts up to three months.</i_keyword>
      <i_keyword>Intervention group:  Rivastigmine starts at 1.5mg twice daily and increases to 3mg twice a week within a week.</i_keyword>
      <i_keyword>Intervention group:  Memantine starts at 5mg daily and increases to 10mg per day in one week.</i_keyword>
      <i_keyword>Intervention group:  Galanthambon is given 8mg daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Transcranial Doppler Sonography. Timepoint: Performing transcranial doppler sonography at the beginning of the study and three months after taking any of the donepezill, memantine, galanthamine or rivastigmine drugs. Method of measurement: Doppler Sonography machine.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mini Mental State Examination. Timepoint: Measurement of the MMSE at the beginning of the study and three months after the onset of consumption, which of the drugs donepezil, memantine, galantamine or rivastigmine. Method of measurement: By number from zero to thirty.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-10</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Campus of the University of Medical Sciences, the center of seven Alavi Gardens, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
