Idiopathic Dilated CardiomyopathyPhase 2/3NCT02987322
Honey in Idiopathic Dilated Cardiomyopathy
A Phase 2/3 study testing honey in people with Idiopathic Dilated Cardiomyopathy, run by mamdouh abdulmaksoud abdulrhman.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Idiopathic Dilated Cardiomyopathy
- What is being tested?
- honey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 -
About this study
Official title: Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Idiopathic Dilated Cardiomyopathy
- Being tested
- honey
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
honeyDietary supplement
Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| honey | Experimental | Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group. Receives: Dietary Supplement: honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection fraction % as measured by echocardiography
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- mamdouh abdulmaksoud abdulrhman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mamdouh abdulmaksoud abdulrhman, Ain Shams University
- Investigators
- Waleed Elgendy, Lecturer, Principal investigator, Ain Shams University, Pediatric departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987322
- Sponsor's protocol ID
- 4472/28.9.2015
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: honey as a complementary or alternative treatment in cardiovascular diseases
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honey Supplementation in Children With Idiopathic Dilated Cardiomyopathy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02987322
- Acronym / sponsor ID
- 4472/28.9.2015
- Conditions
- Idiopathic Dilated Cardiomyopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- mamdouh abdulmaksoud abdulrhmanUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| honey | Experimental | Dietary Supplement: honeyZiziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months for the patients in the honey group. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| honeyZiziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months | Dietary supplement | honey |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: Undecided. honey as a complementary or alternative treatment in cardiovascular diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Elgendy, Lecturer principal investigator
Ain Shams University, Pediatric departement
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing honey in people with Idiopathic Dilated Cardiomyopathy, run by mamdouh abdulmaksoud abdulrhman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection fraction % as measured by echocardiography (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.