Viewing Study NCT02987322



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Study NCT ID: NCT02987322
Status: COMPLETED
Last Update Posted: 2016-12-12
First Post: 2016-11-29

Brief Title: Honey in Idiopathic Dilated Cardiomyopathy
Sponsor: mamdouh abdulmaksoud abdulrhman
Organization: Ain Shams University

Study Overview

Official Title: Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy A Randomized Controlled Study
Status: COMPLETED
Status Verified Date: 2016-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 12gkgday 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 12gkgday 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None