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Trial record 1 of 157 for:    Idiopathic Dilated Cardiomyopathy
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Honey in Idiopathic Dilated Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02987322
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
mamdouh abdulmaksoud abdulrhman, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Idiopathic Dilated Cardiomyopathy Dietary Supplement: honey Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study
Study Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: honey
Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group.
Dietary Supplement: honey
Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months




Primary Outcome Measures :
  1. Ejection fraction % as measured by echocardiography [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987322


Sponsors and Collaborators
mamdouh abdulmaksoud abdulrhman
Investigators
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Principal Investigator: Waleed Elgendy, Lecturer Ain Shams University, Pediatric departement

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Responsible Party: mamdouh abdulmaksoud abdulrhman, professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02987322     History of Changes
Other Study ID Numbers: 4472/28.9.2015
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: honey as a complementary or alternative treatment in cardiovascular diseases
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly