<?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>IRCT2013041613027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-07</date_registration>
      <primary_sponsor>Research adjutancy ,Guilan university of medical sciences</primary_sponsor>
      <public_title>The effect of Donepezil and Memantine combinition on treatment of traumatic brain injury</public_title>
      <acronym></acronym>
      <scientific_title>The Comparative study about effect of Donepezil with and without    Memantine on recovery of cognitive, linguistic dysfunctions and disability rating in traumatic brain injury patients during the subacute phase</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>162</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12977</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Traumatic brain injury.</hc_freetext>
      <i_freetext>Intervention 1: Drug intervention of Donepezil without Memantine in dosage of 5 mg  during 1 month then induction of drug dosage to 10 mg for 2 months . in first 1 month for  Donepezil group one tablet of 5 mg Donepezil and half tablet Memantin placebo at evening,whereas,  next 2 months for Donepezil group one tablet of Donepezil 10 mg and half tablet of Memantine placebo at evening and half tablet of Memantin placebo at morning,. Intervention 2: Drug intervention of Donepezil with Memantine carries out in dosage of 5 mg for each of them during 1 month then will be continued by induction of drug dosage to 10 mg for 2 months. In combined group (Donepezil+Memantine) is offered one tablet of Donepezil 5 mg and half tablet of Memantine 10 mg at evening in first 1 month. Whereas, next 2 months this group  is used one tablet of Donepezil 10 mg and half tablet of Memantine 10 mg at evening and half tablet of Memantine 10 mg at morning. Intervention 3: Control group receive placebo similar to Memantin and Donepezil. in first 1 month one  and half tablet of placebo is used daily(one tablet of  Donepezil placebo and half tablet of Memantine placebo at evening)  in next 2 month 2 tablet of placebo is used daily (one tablet of  Donepezil placebo at evening and half tablet of  Memantin placebo at morning and half other at evening) .</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. Sara Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina educational &amp; therapeutical center, Namjou avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713191</zip>
        <telephone>+98 13 1323 8373</telephone>
        <email>s.ramezanislp@gmail.com</email>
        <affiliation>Guilan Road trauma research center, Rasht, Guilan university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shahrokh Yousefzadeh Chabok</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina educational &amp; therapeutical center, Namjou avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713191</zip>
        <telephone>+98 13 1323 8373</telephone>
        <email>sh.yousefzadeh@gmail.com</email>
        <affiliation>Guilan Road Trauma Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: aphasia patients having post-traumatic cognitive deficit; moderate &amp; severe traumatic brain injury according to GCS at first 24 h; age range between 18-60 years; GOS score 4 &amp; 5; at least 4 years formal education; maximum of aphasia quotient 75 based on P.AD; moderate and severe cognitive deficit(MMSE score&lt;17); post onset discharge time 2-4 weeks(sub-acute phase).&#13;
Exclusion criteria: history of neurological disease including CVA, brain tumor, epilepsy, seizure, Parkinson and dementia...; previous brain trauma; history of psychiatric disorder and using of antipsychotic &amp; antidepressant drugs; history of drug abuse and pre-existing verbal and cognitive deficit; exist of deafness and blindness; appearance of drug's side effects; exist of renal disease, heart disease, hypertension and unwillingness for continue of the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G94*</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>other disorders of brain in diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Drug intervention of Donepezil without Memantine in dosage of 5 mg  during 1 month then induction of drug dosage to 10 mg for 2 months . in first 1 month for  Donepezil group one tablet of 5 mg Donepezil and half tablet Memantin placebo at evening,whereas,  next 2 months for Donepezil group one tablet of Donepezil 10 mg and half tablet of Memantine placebo at evening and half tablet of Memantin placebo at morning,</i_keyword>
      <i_keyword>Drug intervention of Donepezil with Memantine carries out in dosage of 5 mg for each of them during 1 month then will be continued by induction of drug dosage to 10 mg for 2 months. In combined group (Donepezil+Memantine) is offered one tablet of Donepezil 5 mg and half tablet of Memantine 10 mg at evening in first 1 month. Whereas, next 2 months this group  is used one tablet of Donepezil 10 mg and half tablet of Memantine 10 mg at evening and half tablet of Memantine 10 mg at morning.</i_keyword>
      <i_keyword>Control group receive placebo similar to Memantin and Donepezil. in first 1 month one  and half tablet of placebo is used daily(one tablet of  Donepezil placebo and half tablet of Memantine placebo at evening)  in next 2 month 2 tablet of placebo is used daily (one tablet of  Donepezil placebo at evening and half tablet of  Memantin placebo at morning and half other at evening) .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability rate. Timepoint: before of intervention and 3 months after intervention onset. Method of measurement: disability rate scale (DRS).</prim_outcome>
      <prim_outcome>Aphasia quotient. Timepoint: befor of intervention and 3 months after intervention onset. Method of measurement: Persian. aphasia diagnosis (P.AD).</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: before of intervention and 3 month after intervention onset. Method of measurement: mini-mental state examination(MMSE).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of drugs. Timepoint: 1 month and 3 months after intervention onset. Method of measurement: observation and examination.</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>Research adjutancy ,Guilan university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-09</approval_date>
        <contact_name>Research Guilan university of medical sciences</contact_name>
        <contact_address>Rasht, Namjou avenue, Research Guilan university of medical sciences Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
