Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms

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

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

Study Overview

• Status: Recruiting
• Conditions: Allergic Conjunctivitis of Both Eyes; Dry Eye Symptoms
• Intervention / Treatment: Dietary supplement: Kelulut Honey 60 g Oral Supplement; Dietary supplement: Kelulut Honey 120 g Oral Supplement; Other: Honey-Flavoured Zero-Calorie Syrup (Placebo)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharifah Izzati Dr, MD; Phone Number: +6010-2329207; Email: shzatiee@gmail.com

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Recruiting
      • Hospital Pakar Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

i. Any corneal or ocular surface pathology ii. Known diabetes mellitus or impaired glucose test iii. Ocular surface disease due to trachoma or other inflammatory conditions iv. Consume anti-inflammatory medications such as steroids, NSAIDS, oral doxycycline v. Concurrent use of other supplements or alternative therapies such as royal jelly, Manuka honey eye drop or omega-3 fatty acid vi. Using preservative-containing topical eye drops for ocular problems other than AC, such as anti-glaucoma medication vii. History of ocular trauma/surgery or refractive surgery within last 3 years viii. Wearing contact lens in the last 3 months ix. Underlying inflammatory/ systemic disease and connective tissue diseases x. Recent conjunctivitis in the last 3 months xi. Patients on immunosuppressant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Kelulut Honey 60 g Oral Supplement; Participants 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.; Other Names: Group A; KH-60
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.	Dietary supplement: Kelulut Honey 120 g Oral Supplement; Participants 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.; Other Names: Group B; KH-120
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.	Other: Honey-Flavoured Zero-Calorie Syrup (Placebo); Participants 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.; Other Names: Group C; KH-P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1 month
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.	Baseline and 1 month
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.	Baseline and 1 month

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Shahidatul Adha Dr, MD, MMed, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): January 16, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: USM/JEPeM/KK/24080659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study is single-center, involves a small sample size, and institutional data governance policies do not permit open sharing of identifiable clinical data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No