<?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>IRCT20190803044426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Aloe Vera gel in systolic heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the efficacy of “Aloe Vera” oral gel on the quality of life in patients with systolic heart failure : A double blind, randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41286</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used
Blocking is used to balance the number of samples assigned to each study group, because we have two intervention groups, use equal 4 blocks and create all 4 possible modes and then with Excel software we randomly select a number of blocks.
Since the sample size in this study is 26 cases (13 cases in each group), by using Excel software, 7 blocks of 4 are randomly used.
The label of interventions to one of the letters A or B and the sequence of randomization determined by the statistical consultant.
For allocation concealment,drug delivery and the sequence of randomization is not available to researchers and evaluators while is the responsibility of the off-site individual, Blinding description: After evaluation by the researcher, participants are referred to the off-site individual(drug Delivery Person) and receive A or B intervention according to a random sequence list
The drug and placebo are coded in similar capsules and in identical packages, with the same color and participants, researchers, drug Delivery Person and investigators are not aware of treatment allocation. Only the statistician will be unblinded to the treatment assignment.</study_design>
      <phase>3</phase>
      <hc_freetext>Systolic heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Patients will receive Aloe Vera gel capsule two times a day for next 8 weeks.Each capsule contains 150 mg of Aloe Vera gel . The drug will be provided by Shahid Beheshti university pharmacy lab. Intervention 2: Placebo capsule that is identically appearing with Aloe Vera capsule will be administered to patients in placebo group. patients will receive placebo drug two times a day for next 8 weeks. Capsules contain 150 mg starch which will be provided in the Shahid Beheshti university pharmacy lab.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeideh Sabbaghzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.847, Beginning of Behesht St, South side of Park City, Vahdat-e Islamic St, Hassan Abad Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۱۴۷۳۳۳۱۱</zip>
        <telephone>+98 21 5558 0388</telephone>
        <email>sabbaghzadegan.s@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Majid Dadmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.847, Beginning of behesht Street, South Park City, Vahdat Islamic Street, Hassan Abad Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۱۴۷۳۳۳۱۱</zip>
        <telephone>+98 21 5563 9667</telephone>
        <email>dadmehr.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Written informed consent
Age: 18 years or above
Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.
Patients willing to continue their standard continuing heart medications which prescribed by cardiologist
Ambulatory systolic heart failure patients in stable condition (no hospitalization during the trial and no planned surgery)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Breast feeding
Hypersensitivity to Aloe Vera
Chronic Inflammatory disease
Collagen vascular disease
History of peptic ulcer
Acute infectious disease
Decompensated heart failure
Chronic liver disease
Chronic renal failure
Hemorrhoids
Malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic 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>Patients will receive Aloe Vera gel capsule two times a day for next 8 weeks.Each capsule contains 150 mg of Aloe Vera gel . The drug will be provided by Shahid Beheshti university pharmacy lab</i_keyword>
      <i_keyword>Placebo capsule that is identically appearing with Aloe Vera capsule will be administered to patients in placebo group. patients will receive placebo drug two times a day for next 8 weeks. Capsules contain 150 mg starch which will be provided in the Shahid Beheshti university pharmacy lab</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 Aloe Vera gel. Method of measurement: Minnesota Living With Heart Failure Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The distance traveled in six minute walk test. Timepoint: Measure the distance traveled in six minute walk test at the beginning of study (before intervention) and one week after taking the Aloe Vera gel. Method of measurement: Six minute walk test.</sec_outcome>
      <sec_outcome>Insomnia score in the Insomnia Severity Index (ISI) questionnaire. Timepoint: Measure the insomnia score at the beginning of study (before intervention) and one week after taking intervention (Aloe Vera gel). Method of measurement: The Insomnia Severity Index (ISI) questionnaire.</sec_outcome>
      <sec_outcome>Quality of sleep score in the Pittsburgh Sleep Quality Index (PSQI)  questionnaire. Timepoint: Measure the quality of sleep score at the beginning of study (before intervention) and one week after taking intervention (Aloe Vera gel). Method of measurement: The Pittsburgh Sleep Quality Index (PSQI) questionnaire.</sec_outcome>
      <sec_outcome>Obstructive sleep apnea score in STOP-BANG sleep apnea questionnaire. Timepoint: Measure the obstructive sleep apnea score at the beginning of study (before intervention) and one week after taking intervention (Aloe Vera gel). Method of measurement: STOP-BANG sleep apnea 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-27</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
