Honey in Idiopathic Dilated Cardiomyopathy

Phase 2

Completed

• Conditions: Idiopathic Dilated Cardiomyopathy
• Interventions: Dietary Supplement: honey

• Registration Number: NCT02987322
• Lead Sponsor: mamdouh abdulmaksoud abdulrhman

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.

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Study First Submitted: 2016-11-29
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-08
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
honey	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.

Primary Outcome Measures

Name	Time	Method
Ejection fraction % as measured by echocardiography	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.