<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02987322</url>
  </required_header>
  <id_info>
    <org_study_id>4472/28.9.2015</org_study_id>
    <nct_id>NCT02987322</nct_id>
  </id_info>
  <brief_title>Honey in Idiopathic Dilated Cardiomyopathy</brief_title>
  <official_title>Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>mamdouh abdulmaksoud abdulrhman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Honey, as a natural product produced by honey bees, has anti-oxidant,&#xD;
      anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that&#xD;
      honey might have positive effects on cardiovascular diseases.&#xD;
&#xD;
      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2&#xD;
      to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly&#xD;
      assigned into two equal groups: the honey group and the control group. In the honey group,&#xD;
      honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional&#xD;
      treatment of IDC. The patients in the control group received only their standard treatment,&#xD;
      without honey. The main outcome measure was the percent change in the ejection fraction (EF)&#xD;
      and the fraction shortening (FS) shown in echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Honey, as a natural product produced by honey bees, has anti-oxidant,&#xD;
      anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that&#xD;
      honey might have positive effects on cardiovascular diseases.&#xD;
&#xD;
      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2&#xD;
      to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly&#xD;
      assigned into two equal groups: the honey group and the control group. In the honey group,&#xD;
      honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional&#xD;
      treatment of IDC. The patients in the control group received only their standard treatment,&#xD;
      without honey. The main outcome measure was the percent change in the ejection fraction (EF)&#xD;
      and the fraction shortening (FS) shown in echocardiography. Patients in each group were&#xD;
      subjected to history taking, clinical examination and investigations, including ECG and&#xD;
      echocardiography at baseline and end of the study. Patients continued their standard&#xD;
      treatment during the study. The honey used in the study was subjected to physicochemical&#xD;
      analysis before use, and it was kept in closed containers away from light until the time of&#xD;
      administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ejection fraction % as measured by echocardiography</measure>
    <time_frame>3 months</time_frame>
    <description>The main outcome measure is the average increase or decrease of the ejection fraction (expressed as percentage), which refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Idiopathic Dilated Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>honey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>honey</intervention_name>
    <description>Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months</description>
    <arm_group_label>honey</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Echocardiographic diagnosis of dilated cardiomyopathy (DCM), based on the presence of&#xD;
             left ventricular enlargement and systolic dysfunction with an ejection fraction &lt;45%.&#xD;
&#xD;
          2. The echocardiographic findings included left ventricular dilatation and systolic&#xD;
             dysfunction, with or without mitral regurgitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other types of cardiomyopathy&#xD;
&#xD;
          2. Systemic or chronic illness, including cancer, endocrine disorders and sepsis&#xD;
&#xD;
          3. Children with diabetes mellitus&#xD;
&#xD;
          4. Ischemic heart disease diagnosed by coronary angiography or a history of myocardial&#xD;
             infarction&#xD;
&#xD;
          5. Systemic hypertension with a blood pressure &gt;170/100 mm Hg -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waleed Elgendy, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University, Pediatric departement</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>mamdouh abdulmaksoud abdulrhman</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Dilated</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>honey as a complementary or alternative treatment in cardiovascular diseases</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987322
org study id: 4472/28.9.2015
nct id: NCT02987322
lead sponsor: 
has dmc: Yes
Background: Honey, as a natural product produced by honey bees, has anti-oxidant,
      anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that
      honey might have positive effects on cardiovascular diseases.

      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2
      to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly
      assigned into two equal groups: the honey group and the control group. In the honey group,
      honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional
      treatment of IDC. The patients in the control group received only their standard treatment,
      without honey. The main outcome measure was the percent change in the ejection fraction (EF)
      and the fraction shortening (FS) shown in echocardiography.
Background: Honey, as a natural product produced by honey bees, has anti-oxidant,
      anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that
      honey might have positive effects on cardiovascular diseases.

      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2
      to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly
      assigned into two equal groups: the honey group and the control group. In the honey group,
      honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional
      treatment of IDC. The patients in the control group received only their standard treatment,
      without honey. The main outcome measure was the percent change in the ejection fraction (EF)
      and the fraction shortening (FS) shown in echocardiography. Patients in each group were
      subjected to history taking, clinical examination and investigations, including ECG and
      echocardiography at baseline and end of the study. Patients continued their standard
      treatment during the study. The honey used in the study was subjected to physicochemical
      analysis before use, and it was kept in closed containers away from light until the time of
      administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ejection fraction % as measured by echocardiography
time frame: 3 months
description: The main outcome measure is the average increase or decrease of the ejection fraction (expressed as percentage), which refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction.
arm group label: honey
arm group type: Experimental
description: Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group.
intervention type: Dietary Supplement
intervention name: honey
description: Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months
arm group label: honey
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Waleed Elgendy, Lecturer
role: Principal Investigator
affiliation: Ain Shams University, Pediatric departement
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: mamdouh abdulmaksoud abdulrhman
investigator title: professor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Dilated
sharing ipd: Undecided
ipd description: honey as a complementary or alternative treatment in cardiovascular diseases