CClinicalTrials.gg
CompletedNCT02987322Updated Dec 12, 2016

Honey in Idiopathic Dilated Cardiomyopathy

A Phase 2/3 interventional study of honey in Idiopathic Dilated Cardiomyopathy, sponsored by mamdouh abdulmaksoud abdulrhman. Completed. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2016-12-12.

Sponsored by mamdouh abdulmaksoud abdulrhman · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Idiopathic Dilated Cardiomyopathy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 50 is close to the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

mamdouh abdulmaksoud abdulrhman is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 -
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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.

    Dietary Supplement: honey

Interventions

  • Dietary supplementhoney

    Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — honey as a complementary or alternative treatment in cardiovascular diseases

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02987322
Lead sponsor
mamdouh abdulmaksoud abdulrhman
Responsible party
mamdouh abdulmaksoud abdulrhman (professor, Ain Shams University) — Sponsor-investigator
First posted
Dec 8, 2016
Start date
Nov 2015
Primary completion
May 2016
Completion
Nov 2016
Last update
Dec 12, 2016

Study contacts

Waleed Elgendy, Lecturer
principal investigator · Ain Shams University, Pediatric departement

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion