<?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>IRCT20140715018490N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Fasa University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Tanacetum parthenium  on inflammatory and coagulating indexes</public_title>
      <acronym></acronym>
      <scientific_title>To evaluate effectiveness of Tanacetum parthenium (L) Sch. consumption on blood inflammatory and coagulating indexes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28088</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked Randomized Table, Blinding description: Participants, researchers and data analyzer were blinded to the study groups. We made the placebo and therapeutic capsules like each other and labeled them by a letter -A and B.</study_design>
      <phase>3</phase>
      <hc_freetext>Healthy individuals.</hc_freetext>
      <i_freetext>Intervention 1: Treatment group: In this group; capsules with 250 mg Tanacetum parthenium (L) Sch are administrated 1 time per day for 2 weeks. Intervention 2: control group: In this group; capsules with 250 mg corn flour are administrated 1 time per day for 2 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because of ethical considerations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Akrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 34, Western Sahebolamr Ave., North Safir Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7177846939</zip>
        <telephone>+98 71 3820 0533</telephone>
        <email>akrami_e@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr  Mohammadreza Ataollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fasa University of Medical Sciences, Ebnesina square, Fasa, Fars, Iran</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>ataollahimr@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between20  and 60
negative hx of D.M
negative hx of major surgery(Under 6 months)
negative hx of HTN
negative hx of  coagulopathy like hemophilia
negative hx of liver diseases
Satisfaction to participate in the scheme.
not use  anticoaglant drugs and anti inflamatory drugs such as NSAIDs
Not to have bleeding disorders in GI system</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>positive hx of  coagulopathy like hemophilia
positive hx of HTN
positive hx of major surgery(Under 6 months)
positive hx of D.M
liver disease such as cirihosis or hepatitis
Age over 60 or under the age of 20
use  anticoaglant drugs and anti inflamatory drugs such as NSAIDs
Dissatisfaction to participate in the scheme
To have bleeding disorders in GI system
possible complications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: In this group; capsules with 250 mg Tanacetum parthenium (L) Sch are administrated 1 time per day for 2 weeks.</i_keyword>
      <i_keyword>control group: In this group; capsules with 250 mg corn flour are administrated 1 time per day for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prothrombin Time (PT). Timepoint: At the beginning of intervention, 2 weeks and 6 weeks after the beginning of intervention. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>Partial Thromboplastin Time (PTT). Timepoint: At the beginning of intervention, 2 weeks and 6 weeks after the beginning of intervention. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-1β. Timepoint: At the beginning of intervention and 2weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IFN-α. Timepoint: At the beginning of intervention and 2weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IFN-γ. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>TNF-α. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>Monocyte chemotactic  protein-1. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-8. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-10. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-12p70. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-17A. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-18. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-23. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
      <prim_outcome>IL-33. Timepoint: At the beginning of intervention and 2 weeks later. Method of measurement: Venous Blood Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction of patients. Timepoint: 1 month after recruitment. Method of measurement: visual analog scale.</sec_outcome>
      <sec_outcome>Tolerance. Timepoint: 1 month after recruitment. Method of measurement: visual analog scale.</sec_outcome>
      <sec_outcome>Drug side effects. Timepoint: 1 month after recruitment. Method of measurement: Questionnaire.</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, Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-22</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Fasa University of Medical Sciences, Ebnesina square, Fasa Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
