Dry Eye SymptomsNCT07273747
Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms
A study testing Kelulut Honey 60 g Oral Supplement and Kelulut Honey 120 g Oral Supplement in people with Dry Eye Symptoms and Allergic Conjunctivitis of Both Eyes, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye Symptoms, Allergic Conjunctivitis of Both Eyes
- What is being tested?
- Kelulut Honey 60 g Oral Supplement and Kelulut Honey 120 g Oral Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Pakar Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
About this study
Official title: 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:
Read more
- Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis?
- 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)?
- 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:
- Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month
- Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor
- Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health
- 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
- Being tested
- Kelulut Honey 60 g Oral Supplement, Kelulut Honey 120 g Oral Supplement, Honey-Flavoured Zero-Calorie Syrup (Placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kelulut Honey 60 g Oral SupplementDietary supplement
Also called KH-60, Group A
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.
Kelulut Honey 120 g Oral SupplementDietary supplement
Also called KH-120, Group B
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
Also called Group C, KH-P
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Honey-Flavoured Zero-Calorie Syrup (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start17 Sep 2025
- Primary completion16 Jan 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahidatul Adha Mohamad, Universiti Sains Malaysia
- Investigators
- Shahidatul Adha Dr, MD, MMed, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273747
- Sponsor's protocol ID
- USM/JEPeM/KK/24080659
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07273747
- Acronym / sponsor ID
- USM/JEPeM/KK/24080659
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 16 Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis?
- 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)?
- 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:
- Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month
- Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor
- Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kelulut Honey 60 g (KH-60) | Experimental | Dietary Supplement: Kelulut Honey 60 g Oral SupplementKelulut 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 | Dietary Supplement: Kelulut Honey 120 g Oral SupplementKelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms. |
| Placebo | Placebo comparator | Other: Honey-Flavoured Zero-Calorie Syrup (Placebo)The placebo consists of a honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to the Kelulut honey sachets to maintain blinding. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kelulut Honey 60 g Oral SupplementAlso: KH-60, Group AParticipants 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 60 g (KH-60) |
| Kelulut Honey 120 g Oral SupplementAlso: KH-120, Group BParticipants 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. | Dietary supplement | Kelulut Honey 120 g (KH-120) |
| Honey-Flavoured Zero-Calorie Syrup (Placebo)Also: Group C, KH-PParticipants 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 | Placebo |
Primary outcome
Change in conjunctival goblet cell density (GCD)
Time frame: Baseline and 1 month
Goblet cell density measured via impression cytology and quantified using standard morphological grading. Change from baseline to 1 month will be compared between groups.
3 secondary outcomes
Change in tear film break-up time (TBUT)
Time frame: Baseline and 1 month
Change in ocular surface staining score (OGS)
Time frame: Baseline and 1 month
Change in Ocular Surface Disease Index (OSDI) score
Time frame: Baseline and 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shahidatul Adha Dr, MD, MMed principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kelulut Honey 60 g Oral Supplement and Kelulut Honey 120 g Oral Supplement in people with Dry Eye Symptoms and Allergic Conjunctivitis of Both Eyes, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharifah Izzati Dr, MD (+6010-2329207, shzatiee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in conjunctival goblet cell density (GCD) (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.