Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversiti Sains Malaysia
About this trial
The goal of this clinical trial is to learn if oral Kelulut honey works to improve eye symptoms in adults with allergic conjunctivitis. It will also look at how safe Kelulut honey is when taken as a daily supplement.
The main questions it aims to answer are:
1. Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis? 2. Does oral Kelulut honey improve tear film stability and the health of conjunctival goblet cells (special cells on the eye surface that help keep the eye moist)? 3. What side effects or medical problems do participants have when taking Kelulut honey?
Researchers will compare oral Kelulut honey to a honey-flavoured placebo syrup (a look-alike drink that does not contain Kelulut honey) to see if Kelulut honey is more effective than placebo for treating eye symptoms in allergic conjunctivitis.
Participants will:
1. Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month 2. Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor 3. Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health 4. Answer questionnaires about their eye symptoms and how these affect their daily activities and vision-related quality of life
Participation is voluntary, and participants may stop taking part in the study at any time. Data collected up to the time they withdraw may still be used for research, but their routine medical care will not be affected
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Kelulut Honey 60 g Oral Supplement
Dietary supplementParticipants in this arm will consume two 30 g sachets of Kelulut honey once daily (total 60 g/day) for one month. The honey will be taken directly from the sachet without dilution, on an empty stomach, 30 minutes before breakfast. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.
Kelulut Honey 120 g Oral Supplement
Dietary supplementParticipants in this arm will consume four 30 g sachets of Kelulut honey daily (total 120 g/day) for one month. The daily dose will be divided into two administrations: two sachets before breakfast or lunch, and two sachets before dinner. The honey will be taken directly from the sachets without dilution, at least 30 minutes before meals. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.
Honey-Flavoured Zero-Calorie Syrup (Placebo)
Other interventionParticipants in this placebo group will receive honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to those used for the Kelulut honey. Each participant will consume two sachets per day, to be taken daily, once before breakfast, for one month duration. The syrup is to be taken directly from the sachets, without dilution, before meals.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Kelulut Honey 60 g (KH-60)Experimental treatment 1 intervention
Group B: Kelulut Honey 120 g (KH-120)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in conjunctival goblet cell density (GCD)
Goblet cell density measured via impression cytology and quantified using standard morphological grading. Change from baseline to 1 month will be compared between groups.
Time frame
Baseline and 1 monthSecondary outcomes
1
Change in tear film break-up time (TBUT)
TBUT measured using fluorescein dye under slit-lamp examination. Change from baseline to 1 month will be compared between groups.
Time frame
Baseline and 1 month2
Change in ocular surface staining score (OGS)
Corneal and conjunctival fluorescein staining graded using the Oxford Grading Scheme (0-5). Change from baseline to 1 month will be compared between groups.
Time frame
Baseline and 1 month3
Change in Ocular Surface Disease Index (OSDI) score
OSDI questionnaire score assessing dry eye symptoms and functional impact. Change from baseline to 1 month will be compared between groups.
Time frame
Baseline and 1 monthSponsors and contacts
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Source ClinicalTrials.gov