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Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms

NCT07273747 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-09

No results posted yet for this study

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

Conditions

  • Dry Eye Symptoms
  • Allergic Conjunctivitis of Both Eyes

Interventions

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.

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

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.

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Shahidatul Adha Dr, MD, MMed · Universiti Sains Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2026-01-16
Completion
2026-09-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273747 on ClinicalTrials.gov