<?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>IRCT20170227032797N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-05</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Dorema ammoniacum and acupuncture in treatment of cerebral stroke</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Dorema ammoniacum  and acupuncture on the clinical improvement of patients with cerebral stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>57</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25469</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned into three categories: A, B, and C using Random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first intervention group, standardized treatment and physiotherapy, and also Dorema ammoniacum gum with a daily dose of one gram is given as an oral capsule, twice a day for one month. Intervention 2: Intervention group: The second intervention group receives the standard treatment and physiotherapy and also acupuncture treatment provided by an acupuncturist. The number of acupuncture sessions is twelve 30 minute sessions, three times a week. Intervention 3: Control group: In the control group, standard treatment and physiotherapy are received.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Mehrpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine and Supplement, Mashhad University of Medical Sciences, Ferdowsi University, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00985138848931</zip>
        <telephone>+98 51 3884 8931</telephone>
        <email>mehrpourm911@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamid Reza Bahrami Taghanaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Traditional Medicine and Supplement, Mashhad University of Medical Sciences, Ferdowsi University, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>917794-8564</zip>
        <telephone>+98 51 3884 8931</telephone>
        <email>bahramihr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with focal neurological findings that have been clinically and with brain imaging have been diagnosed with ischemic stroke
Ischemia is in the superior branch of middle cerebral artery
Stroke attack in less than thirty days
Age between 50 and 75 years
First stroke attack
Modified NIHSS between 4 and 20
Patient with consciousness and stable disease condition</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cerebral stroke of hemorrhagic type
Patients suffering from systemic chronic diseases such as: uncontrolled diabetes, severe liver, cardiac, renal or pulmonary disorders or cancer
Patients taking coagulants (heparin or warfarin)
Patients with BMI above 35
Patients with history of acupuncture in less than a month
Patients with a history of allergy to Dorema Ammoniacum
Patient suffering from severe musculoskeletal or neurologic diseases before ischemic stroke
Patients diagnosed with tumor or skin infections</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first intervention group, standardized treatment and physiotherapy, and also Dorema ammoniacum gum with a daily dose of one gram is given as an oral capsule, twice a day for one month.</i_keyword>
      <i_keyword>Intervention group: The second intervention group receives the standard treatment and physiotherapy and also acupuncture treatment provided by an acupuncturist. The number of acupuncture sessions is twelve 30 minute sessions, three times a week.</i_keyword>
      <i_keyword>Control group: In the control group, standard treatment and physiotherapy are received.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability due to cerebral stroke. Timepoint: Before the intervention, After the end of the intervention. Method of measurement: MNIHSS and mRankin scales.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Aspartate aminotransferase. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Low density lipoprotein. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>High density lipoprotein. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Alanine aminotransferase. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Blood urea nitrogen. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Glycosylated hemoglobin. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Complete Blood Count. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Partial thromboplastin time. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Prothrombin Time. Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>International Normalized Ratio (INR). Timepoint: before intervention and after the end of intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: before intervention and after the end of intervention. 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-07</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ethics committee of Mashhad University of Medical Sciences, Quraishi Building, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
