Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Ejection fraction % as measured by echocardiography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 -
结局指标
主要结局
Ejection fraction % as measured by echocardiography
时间窗: 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.
次要结局
未报告次要终点
研究者
mamdouh abdulmaksoud abdulrhman
professor
Ain Shams University
