<?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>IRCT20190129042540N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-26</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of achillea Mellifolium in Ischemic Stroke</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of achillea millefolium  on disability and functional state of ischemic stroke patients, A clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68954</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization was done using free web-based systems, Blinding description: Participants do not know which drug is placebo and which is the main drug.
The follower of drug prescription and the examiner of the  results of function and quality of life are unaware of the type of drug.</study_design>
      <phase>3</phase>
      <hc_freetext>Ischemic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Treatment group: Stroke patients are randomly assigned to the treatment group. People in this group receive yarrow capsules. Capsules in a dose of 500 mg are prepared from the aqueous extract of flowering branches and yarrow leaves. First, the plant is purchased from the Isfahan herbarium after the herbarium expert confirms the species. Then it is cleaned, thoroughly washed, and dried in a cool and dark place.  The capsules are extracted and prepared at Barich Essence pharmaceutical company (4 grams of plant powder is brewed in 200 ml of distilled water for 20 minutes and then the extract is separated and dried). Patients take one capsule daily, preferably with food, for 3 months. Achillea extract has anti-inflammatory and neuroprotective properties due to the presence of apigenin and luteolin and improves CNS function. So far, the effects of this medicinal plant have been studied on MS and several other inflammatory diseases , but it has not been studied on stroke. Intervention 2: Control group:  Control group: The other group of cerebral ischemia stroke patients randomly use cellulose capsules made by Barij Essan company with the same shape and weight as the drug for three months.</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:
All the data obtained in the study will be made available to the public after being de-identified through the writing of the article.

When:
The data will be published after the conclusion of the research plan and the statistical analysis of the findings and the preparation of the results in about two years.

To whom:
The data does not belong to specific people and the results are available to the public.

Conditions:
There is no special condition for using the data and the public can use the results.

Where to obtain:
The data will be published as an article, and if needed, it will be available through correspondence with the corresponding author's email.

How to obtain:
The  applicant can contact the corresponding author via email and send a request for access to the results

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Vakilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13,4th Alley, Emam Avenue</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717937555</zip>
        <telephone>+98 34 3428 9393</telephone>
        <email>alirezavakilian66@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Vakilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13,4th Alley, Emam Avenue</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717937555</zip>
        <telephone>+98 34 3428 9393</telephone>
        <email>alirezavakilian66@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ischemic stroke for the first time
satisfy to participate
nihss less than 25
age more than 18</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The use of alteplase in treatment
impaired swallowing
pregnancy or intend to be pregnant
using other herbal medicine
allergy to achillea millefolium</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment group: Stroke patients are randomly assigned to the treatment group. People in this group receive yarrow capsules. Capsules in a dose of 500 mg are prepared from the aqueous extract of flowering branches and yarrow leaves. First, the plant is purchased from the Isfahan herbarium after the herbarium expert confirms the species. Then it is cleaned, thoroughly washed, and dried in a cool and dark place.  The capsules are extracted and prepared at Barich Essence pharmaceutical company (4 grams of plant powder is brewed in 200 ml of distilled water for 20 minutes and then the extract is separated and dried). Patients take one capsule daily, preferably with food, for 3 months. Achillea extract has anti-inflammatory and neuroprotective properties due to the presence of apigenin and luteolin and improves CNS function. So far, the effects of this medicinal plant have been studied on MS and several other inflammatory diseases , but it has not been studied on stroke.</i_keyword>
      <i_keyword>Control group:  Control group: The other group of cerebral ischemia stroke patients randomly use cellulose capsules made by Barij Essan company with the same shape and weight as the drug for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability scale. Timepoint: First and 3 months later. Method of measurement: Questionnaire of  NIHS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional state. Timepoint: First and 3 months later. Method of measurement: Questionnaire of  Modified Rankin Scale (mRS).</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-06</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences Ethics committee</contact_name>
        <contact_address>Imam Ali boulevard Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
