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Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

ConditionsJuvenile Open Angle GlaucomaDry Eye Disease (DED)Interleukin 6Retinal Nerve Fiber Layer ThicknessHbA1c Level
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age15-40
SponsorUniversiti Sains Malaysia

About this trial

The goal of this clinical trial is to evaluate the effects of stingless bee honey (Kelulut honey) in juvenile open-angle glaucoma patients. The study evaluates the effects on serum Interleukin 6 level(IL-6), retinal nerve fiber layer(RNFL) thickness and dry eye-related symptoms. A total of 60 participants who meet the study criteria will be randomly assigned to one of two groups. One group will consume 30 grams of Kelulut honey daily for a period of three months, while the control group will not receive honey or a placebo. Serum IL-6 level, RNFL thickness, Tear break up time (TBUT) and Schirmer Test 1 will be done before and after 90 days. Adherence to honey consumption will be monitored using a daily diary. This study aims to provide better understanding of the potential role of Kelulut honey as a supplementary therapy in patients with juvenile open-angle glaucoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stingless bee honey (Kelulut)

    Biological/Vaccine

    Kelulut is stingless bee honey, a natural biologic product produced by stinglee bee species.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Honey groupActive comparator 1 intervention
Group B: Non-honey groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in the level of serum Interleukin-6 level before and after consumption of stingless bee honey for 3 months among patients with juvenile open angle glaucoma

Blood taking will be done to evaluate any change in the level of interleukin -6

Time frame
from the enrolment to the end of study at 90 days
2

serum Interleukin 6 level

Measurement of serum level of Interleukin-6

Time frame
90 days

Secondary outcomes

1

Change in the retinal nerve fiber layer thickness before and after consumptio of stingless bee honey in patients with juvenile open angle glaucoma

Thickness of retinal nerve fiber layer is measured using Optical Coherence Tomography

Time frame
From enrollment to the end of the treatment at 90 days

Other outcomes

1

change in the dry eye disease parameters

Tear break-up time and Schirmer test evaluation will be done on each subjects

Time frame
From enrollment until the end of study at 90 days
2

Change in the level of glycated hemoglobin pre and post consumption of stingless honey kelulut

Measurement of glycated hemoglobin will be done

Time frame
From enrollment until the completion of study at 90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Sains Malaysia

Lead sponsor

Hospital Universiti Sains Malaysia

Sponsor institution

Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan

Collaborator

Hospital Sultanah Nur Zahirah, Kuala Terengganu

Collaborator

Hospital Universiti Sains Malaysia

Collaborator

Source ClinicalTrials.gov
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