Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharifah Izzati Dr, MD | Contact | +6010-2329207 | shzatiee@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shahidatul Adha Dr, MD, MMed | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pakar Universiti Sains Malaysia | Recruiting | Kota Bharu | Kelantan | 16150 | Malaysia |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
| 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. |
|
|
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 |