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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02987322 |
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Date of registration:
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29/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Honey in Idiopathic Dilated Cardiomyopathy
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Scientific title:
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Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02987322 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Contacts
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Name:
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Waleed Elgendy, Lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ain Shams University, Pediatric departement |
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Key inclusion & exclusion criteria
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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 -
Age minimum:
2 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Dilated Cardiomyopathy
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Intervention(s)
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Dietary Supplement: honey
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Primary Outcome(s)
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Ejection fraction % as measured by echocardiography
[Time Frame: 3 months]
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Secondary ID(s)
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4472/28.9.2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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