Honey in Idiopathic Dilated Cardiomyopathy
Primary Purpose
Idiopathic Dilated Cardiomyopathy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
honey
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Dilated Cardiomyopathy
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 -
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
NCT ID
NCT02987322
First Posted
November 29, 2016
Last Updated
December 8, 2016
Sponsor
mamdouh abdulmaksoud abdulrhman
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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