Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms

Universiti Sains Malaysia

Status: Enrolling

Conditions: Dry Eye Symptoms; Allergic Conjunctivitis of Both Eyes

Treatments: Dietary Supplement: Kelulut Honey 120 g Oral Supplement; Dietary Supplement: Kelulut Honey 60 g Oral Supplement; Other: Honey-Flavoured Zero-Calorie Syrup (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07273747

USM/JEPeM/KK/24080659

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

Kelulut Honey 60 g (KH-60)

Experimental group

Description:

Kelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms.

Treatment:

Dietary Supplement: Kelulut Honey 60 g Oral Supplement

Kelulut Honey 120 g (KH-120)

Experimental group

Description:

Kelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms.

Treatment:

Dietary Supplement: Kelulut Honey 120 g Oral Supplement

Placebo

Placebo Comparator group

Description:

The placebo consists of a honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to the Kelulut honey sachets to maintain blinding.

Treatment:

Other: Honey-Flavoured Zero-Calorie Syrup (Placebo)