<?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>IRCT20180206038645N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-05</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Rheum palmatum root in systolic heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of the effect of "Rheum palmatum root"on quality of life in patients with systolic heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29597</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using random numbers table patiends are divided in two 30 person case_control groups, Blinding description: All participations and researchers are blind in this study, coding of medicine and placebo are under the responsibility of a statistical adviser who is not blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Systolic heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dry extract of Rheum palmatum root with a concentration of 10% relative to 100 gr of roots of the plant, has been standardized 250mg per capsule at the school of pharmacy of Shahid Behest university of Medical Sciences.The drug is given one capsule every 12 hours for 60 days to volunteer patients with heart failure who have ejection fraction equal to or less than 40%. Intervention 2: Control group: Placebo in the control group contains starch corn which is provided in capsules and boxes of the same intervention group at the school of Pharmacy of Shahid Behest university of Medical Sciences.The placebo is given one capsule every 12 hours for 60 days to volunteer patients with heart failure who have ejection fraction equal to or less than40%.</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>Justification or reason for indecision in sharing IPD is THe way of publishing is not known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Education and Treatment Center of ValiaSr, ValiaSr Sq.  Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515777978</zip>
        <telephone>+98 24 3377 0801</telephone>
        <email>gholami1393@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Ahangar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Special clinic in zanjan university of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4518617384</zip>
        <telephone>+98 24 3356 5333</telephone>
        <email>ahanghar@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed study participation
Age 40 to 75
Systolic heart failure with ejection fraction equal or lesser than 40 percent
Continuing heart medications prescribed by cardiologist</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Breast feeding
Malignancy
Hypersensivity to rheum palmatum root
Unwillingness of the patient to continue coperation
Chronic Inflamatory diseas
Severe Renal failure
Collagen vascular disease
Sever liver disease
Acute infectious disease
De compensated heart failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Systolic (congestive) heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dry extract of Rheum palmatum root with a concentration of 10% relative to 100 gr of roots of the plant, has been standardized 250mg per capsule at the school of pharmacy of Shahid Behest university of Medical Sciences.The drug is given one capsule every 12 hours for 60 days to volunteer patients with heart failure who have ejection fraction equal to or less than 40%</i_keyword>
      <i_keyword>Control group: Placebo in the control group contains starch corn which is provided in capsules and boxes of the same intervention group at the school of Pharmacy of Shahid Behest university of Medical Sciences.The placebo is given one capsule every 12 hours for 60 days to volunteer patients with heart failure who have ejection fraction equal to or less than40%</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life Score in the Minnesota Questionnaire. Timepoint: Measure the quality of life score at the beginning of study(before intervention)and one week after taking the Rheum Palmatum Root Extract. Method of measurement: Minnesota Living With Heart Failure Questionnaire.</prim_outcome>
      <prim_outcome>The distance traveled in six minute walk test. Timepoint: Measure the distance traveled in six minute walk test at the beagining of study(before intervention)and one week after taking the Rheum Palmatum Root Extract. Method of measurement: Six minute walk test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Left ventricular ejection fraction. Timepoint: Measurement of left ventricular ejection fraction at the beginning of study (before intervention). Method of measurement: Ecocardiography.</sec_outcome>
      <sec_outcome>Complete blood count. Timepoint: Measurement of complete blood count at the begining of study(before intervention)and one week after taking Rheum Palmatum Root Extract. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Cr. Timepoint: Measurement  of creatinine at the beginning of study (be a for intervention) and one week after taking Rheum palmatum root extract. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>ALT. Timepoint: Measurement of Alanin Aminotransfers at the beginning of first study (be a for intervention) and one week after taking Rheum palmatum root extract. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>AST. Timepoint: Measurement of Aspartat Aminotransferas at the begining first study (be a for intervention) and one week after taking Rheum palmatum root extract. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>CRP. Timepoint: Measurement of C_Reactive Protein at the beginning of first study (be a for intervention) and one week after taking Rheum palmatum extract. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>ALKP. Timepoint: Measurement of Alkaline phosphatas at the beginning of study (be a for intervention) and one week after taking Rheum palmatum extract. 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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-23</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Ethics committee San Jan University of Medical Sciences, A said Sq, Josh our Islamic Ave Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
