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Trial record 1 of 160 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

Tracking Information
First Submitted Date  ICMJE November 29, 2016
First Posted Date  ICMJE December 8, 2016
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02987322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Honey in Idiopathic Dilated Cardiomyopathy
Official Title  ICMJE Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Dilated Cardiomyopathy
Intervention  ICMJE Dietary Supplement: honey
Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: honey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02987322
Other Study ID Numbers  ICMJE 4472/28.9.2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: honey as a complementary or alternative treatment in cardiovascular diseases
Responsible Party mamdouh abdulmaksoud abdulrhman, Ain Shams University
Study Sponsor  ICMJE mamdouh abdulmaksoud abdulrhman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Waleed Elgendy, Lecturer Ain Shams University, Pediatric departement
PRS Account Ain Shams University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP