Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms

NCT07273747 | Recruiting

• 1 other identifier: USM/JEPeM/KK/24080659
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis?
2. 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. 3.What side effects or medical problems do participants have when taking Kelulut honey?
4. 4.Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month
5. 5.Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor
6. 6.Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health
7. 7.Answer questionnaires about their eye symptoms and how these affect their daily activities and vision-related quality of life

Conditions

Dry Eye Symptoms; Allergic Conjunctivitis of Both Eyes

Outcome Measures

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.

  Baseline and 1 month

Secondary Outcomes (3)

• Change in tear film break-up time (TBUT)

  Baseline and 1 month

• Change in ocular surface staining score (OGS)

  Baseline and 1 month

• Change in Ocular Surface Disease Index (OSDI) score

  Baseline and 1 month

Study Arms (3)

Kelulut Honey 60 g (KH-60)

EXPERIMENTAL

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

Kelulut Honey 120 g (KH-120)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

Kelulut Honey 60 g Oral Supplement DIETARY_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.

Also known as: KH-60, Group A

Kelulut Honey 60 g (KH-60)

Kelulut Honey 120 g Oral Supplement DIETARY_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.

Also known as: KH-120, Group B

Kelulut Honey 120 g (KH-120)

Honey-Flavoured Zero-Calorie Syrup (Placebo) OTHER

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.

Also known as: Group C, KH-P

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Pakar Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shahidatul Adha Dr, MD, MMed

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharifah Izzati Dr, MD

CONTACT

+6010-2329207; shzatiee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 9, 2025
• Study Start: September 17, 2025
• Primary Completion: January 16, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)