A Randomized Controlled Trial on the Effects of Oral Kelulut Honey Supplementation on Conjunctival Goblet Cell Density, Tear Film Stability, Dry Eye Disease Symptoms and Vision-Related Function in Patients With Allergic Conjunctivitis

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• i. Age between 18-40 years old ii. Confirmed diagnosis of allergic conjunctivits iii. Ocular surface disease index (OSDI) score \> 12 iv. Compliance to conventional allergic conjunctivitis treatment

Locations
Other Locations
Malaysia
Hospital Pakar Universiti Sains Malaysia
RECRUITING
Kota Bharu
Contact Information
Primary
Sharifah Izzati Dr, MD
shzatiee@gmail.com
+6010-2329207
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2026-09
Participants
Target number of participants: 72
Treatments
Experimental: Kelulut Honey 60 g (KH-60)
Kelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms.
Experimental: Kelulut Honey 120 g (KH-120)
Kelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms.
Placebo_comparator: Placebo
The placebo consists of a honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to the Kelulut honey sachets to maintain blinding.
Sponsors
Leads: Universiti Sains Malaysia

This content was sourced from clinicaltrials.gov

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