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Honey in Idiopathic Dilated Cardiomyopathy

Primary Purpose

Idiopathic Dilated Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
honey
Sponsored by
mamdouh abdulmaksoud abdulrhman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Dilated Cardiomyopathy

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Echocardiographic diagnosis of dilated cardiomyopathy (DCM), based on the presence of left ventricular enlargement and systolic dysfunction with an ejection fraction <45%.
  2. The echocardiographic findings included left ventricular dilatation and systolic dysfunction, with or without mitral regurgitation

Exclusion Criteria:

  1. Other types of cardiomyopathy
  2. Systemic or chronic illness, including cancer, endocrine disorders and sepsis
  3. Children with diabetes mellitus
  4. Ischemic heart disease diagnosed by coronary angiography or a history of myocardial infarction
  5. Systemic hypertension with a blood pressure >170/100 mm Hg -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    honey

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Ejection fraction % as measured by echocardiography
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2016
    Last Updated
    December 8, 2016
    Sponsor
    mamdouh abdulmaksoud abdulrhman
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02987322
    Brief Title
    Honey in Idiopathic Dilated Cardiomyopathy
    Official Title
    Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    mamdouh abdulmaksoud abdulrhman

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Dilated Cardiomyopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    honey
    Arm Type
    Experimental
    Arm 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(s)
    honey
    Intervention Description
    Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months
    Primary Outcome Measure Information:
    Title
    Ejection fraction % as measured by echocardiography
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Echocardiographic diagnosis of dilated cardiomyopathy (DCM), based on the presence of left ventricular enlargement and systolic dysfunction with an ejection fraction <45%. The echocardiographic findings included left ventricular dilatation and systolic dysfunction, with or without mitral regurgitation Exclusion Criteria: Other types of cardiomyopathy Systemic or chronic illness, including cancer, endocrine disorders and sepsis Children with diabetes mellitus Ischemic heart disease diagnosed by coronary angiography or a history of myocardial infarction Systemic hypertension with a blood pressure >170/100 mm Hg -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Waleed Elgendy, Lecturer
    Organizational Affiliation
    Ain Shams University, Pediatric departement
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    honey as a complementary or alternative treatment in cardiovascular diseases

    Learn more about this trial

    Honey in Idiopathic Dilated Cardiomyopathy

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