<?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>IRCT2015122025622N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-29</date_registration>
      <primary_sponsor>Vice chancellor for research,Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>evaluation of an ITM – based protocol on clinical improvement of CVA</public_title>
      <acronym>CVA:cerebro vascular attack</acronym>
      <scientific_title>Explanation of cerebrovascular attack (CVA) based on Iranian traditional medicine (ITM) and evaluation of clinical trial an ITM – based protocol  and modern medical- based protocol on clinical improvement of CVA</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21389</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this randomized study is done based on random numbers table.</study_design>
      <phase>2</phase>
      <hc_freetext>Ischemic cerebro vascular attack.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group, in addition to the current anti-ischemic drugs, ITM, based protocol will be prescribed. - Traditional Therapy package includes an oral syrup safflower extract and safflower oil is a nasal drop. Venice is a barley soup  (including barley, celery, prune, tamarind, candy and a little salt and turmeric) is included in the patient's diet - dose nasal drops 3 drops in each nostril every 4 hours Mybashd.bh a month - barley soup In the first two weeks the patient will be referred to the main course. A 100 ml bottle of safflower syrup prepared with a concentration of 25% by volume weight twice daily to patients is recommended every 5 ml of the syrup mill. For a month. Intervention 2: Routin anti-ischemic drugs plus a placebo given to the control group. Current treatments include aspirin 325 mg daily, and 20 mg Trvstatyn and, if not above the patient's creatinine is 30 cc daily Piracetam. Inert placebo form of the drug is similar to the intervention group.</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>Delshad Elahe</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>opposite the Mehran sports hall,  East Razi Street, Dahe day Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3855 2188</telephone>
        <email>delshade911@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Delshad Elahe</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>opposite of the Mehran sports hall, East Razi Street, dahe day Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3732 7620</telephone>
        <email>delshade911@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In our study, the inclusion criteria encompassed patients whom were discovered to have focal neurological symptoms after their brain imaging, being diagnosed with ischemic CVA. &#13;
On the other hand, the exclusion criteria were as follows: 1. patients with focal neurological findings ith regard to the candidate symptoms of venous rTPA; 2. patients with symptoms in less than 24 hours of a TIA with normal imaging raises; 3. patients on admission with NIHSS Score and analytically based on a bad prognosis. 4. patients with chronic systemic diseases such as uremia, chronic liver disease, and high blood pressure  a potential impact would be on our protocol and our intervention would accelerate HIV disease; 6. patients with possible teratogenic effects of safflower pregnancy; 7. patients having any evidence of brain hemorrhage; 8. patients receiving anticoagulant (heparin or warfarin); 9. incidence of venous infarcts in venous sinus thrombosis; 10. patients reluctant to continue double-blind treatment. During hospitalization, the patients were visited on a daily basis by experts who closely supervised the treatment.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4*</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>cerebro vascular syndrom</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>The intervention group, in addition to the current anti-ischemic drugs, ITM, based protocol will be prescribed. - Traditional Therapy package includes an oral syrup safflower extract and safflower oil is a nasal drop. Venice is a barley soup  (including barley, celery, prune, tamarind, candy and a little salt and turmeric) is included in the patient's diet - dose nasal drops 3 drops in each nostril every 4 hours Mybashd.bh a month - barley soup In the first two weeks the patient will be referred to the main course. A 100 ml bottle of safflower syrup prepared with a concentration of 25% by volume weight twice daily to patients is recommended every 5 ml of the syrup mill. For a month</i_keyword>
      <i_keyword>Routin anti-ischemic drugs plus a placebo given to the control group. Current treatments include aspirin 325 mg daily, and 20 mg Trvstatyn and, if not above the patient's creatinine is 30 cc daily Piracetam. Inert placebo form of the drug is similar to the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of disability based on Questionnaire NIHSS. Timepoint: Baseline and one month after presentation. Method of measurement: Clinical examination by an expert on the NIHSS score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Biochemical markers. Timepoint: Baseline and one month after the initial visit. Method of measurement: blood test.</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,Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-13</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghoreshi department, Avenue Daneshgah, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
