<?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>IRCT20170202032367N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of L-arginine supplementation in patients with congestive heart failure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of L-Arginine supplementation on the levels of glucose, N-Terminal pro Brain Natriuretic Peptide (NT pro-BNP), lipids, blood pressure, ejection fraction, quality of life and rehabilitation in patients with congestive heart failure.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34323</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Regarding to the diabetic status, patients were randomly classified into two groups to receive either L-arginine-supplement or placebo. Stratified Blocked Randomization method was used to randomly assign patients to study groups, Blinding description: In order to blinding the allocation, similar boxes of L-arginine or placebo were labeled by an independent person as A or B.
Patients, the main researcher and the cardiologist were blind in this study.</study_design>
      <phase>3</phase>
      <hc_freetext>congestive heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: L-Arginine supplement (3 g / day) after breakfast, lunch, dinner for 10 weeks.take it orally and this supplement produced by Karen company. Intervention 2: Placebo group: Oral placebo (including maltodextrin) 3 times daily after breakfast, lunch, dinner for 10 weeks orally. Placebo is quite similar in appearance, color, odor and taste. Produced by Karen.</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 The patient's anthropometric and clinical information is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Salmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Departmant of Nutrition and Dietetic, No 44, Hojatdoost avenue, Naderi street, Keshavarz boulevard, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>+98 21 7748 9968</telephone>
        <email>mahnazsalmani1990@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Departmant of Nutrition and Dietetic, No 44, Hojatdoost avenue, Naderi street, Keshavarz boulevard, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416643931</zip>
        <telephone>+98 21 8895 5975</telephone>
        <email>h-imani@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 35-60 years
Diagnosis of ischemic heart failure
Ejection fraction less than 40% (based on echocardiography test)
Cardiac functional level of 2 or 3 based on the classification of the New York heart association</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Kidney, liver or inflammatory bowel diseases, malignancies, thyroid disorders
Pregnancy and lactation
Taking any dietary supplement including L-arginine within the  past 2 months prior to the initiation of the study
History of angina pectoris, myocardial infarction or stroke, untreated arrhythmias
Taking medications including glucocorticoids, antiarrhythmic or chemotherapy agents, NSAIDs, diltiazem, verapamil, thiazolidinedione
Unable to perform 6 minute walking test</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: L-Arginine supplement (3 g / day) after breakfast, lunch, dinner for 10 weeks.take it orally and this supplement produced by Karen company.</i_keyword>
      <i_keyword>Placebo group: Oral placebo (including maltodextrin) 3 times daily after breakfast, lunch, dinner for 10 weeks orally. Placebo is quite similar in appearance, color, odor and taste. Produced by Karen.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Triglyceride. Timepoint: Before and after of intervention. Method of measurement: Enzymatic method with auto analyzer- mg/dl.</prim_outcome>
      <prim_outcome>Serum Total cholestrol. Timepoint: Before and after of intervention. Method of measurement: Enzymatic method with auto analyzer- mg/dl.</prim_outcome>
      <prim_outcome>Serum Low Density Lipoprotein Cholestrol ( LDL-C ). Timepoint: Before and after of intervention. Method of measurement: Calculate according to fridval formula - mg/dl.</prim_outcome>
      <prim_outcome>Serum High Density Lipoprotein Cholestrol ( HDL-C. Timepoint: Before and after of intervention. Method of measurement: Enzymatic method with autoanalyzer- mg/dl.</prim_outcome>
      <prim_outcome>N-terminal pro brain natriuretic peptide. Timepoint: Before and after of intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Fasting Blood Sugar. Timepoint: Before and after of intervention. Method of measurement: Glucose oxidase.</prim_outcome>
      <prim_outcome>The Minnesota Quality of Life Questionnaire. Timepoint: Before and after of intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Left ventricular ejection fraction. Timepoint: Before and after of intervention. Method of measurement: Left ventricular EF percentage for echocardiography.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before and after of intervention. Method of measurement: Digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before and after of intervention. Method of measurement: Digital sphygmomanometer.</prim_outcome>
      <prim_outcome>Distance traveled on 6 minute walk test. Timepoint: Before and after of intervention. Method of measurement: Distance walked in 6 minutes (standard walking route).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-06</approval_date>
        <contact_name>Ethic Committee Tehran University of Medical Sciences</contact_name>
        <contact_address>No 605 room, Sixth floor, Central building of Tehran University of Medical Sciences, Keshavarz boulevard, Ghods street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
