Juvenile Open Angle GlaucomaPhase 4HONEY-JOAGNCT07396441
Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye
A Phase 4 study testing Stingless bee honey (Kelulut) in people with Juvenile Open Angle Glaucoma and Dry Eye Disease (DED), run by Universiti Sains Malaysia at 4 sites in Malaysia.
Trial summary
The goal of this clinical trial is to evaluate the effects of stingless bee honey (Kelulut honey) in juvenile open-angle glaucoma patients. The study evaluates the effects on serum Interleukin 6 level(IL-6), retinal nerve fiber layer(RNFL) thickness and dry eye-related symptoms. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Juvenile Open Angle Glaucoma, Dry Eye Disease (DED), Interleukin 6
- What is being tested?
- Stingless bee honey (Kelulut)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesMalaysia
- Study dates
- 15 Jan 2026to 30 Jun 2026
- Phase
- Phase 4
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- JOAG patients age 15 years old and above until 40 years old at the time of diagnosis Compliant to conventional treatment achieved target intraocular pressure
Who cannot join
- Patients with allergy to honey or honey-based products OCT signal less than 6/10 Concurrent retinal diseases and other optic neuropathies Systemic neurodegenerative disease Systemic comorbidities such as diabetes mellitus and autoimmune diseases Patients on other honey-based products for the last 3 months Patient who consumes honey-based products during the study duration of 3 months (monitoring via honey-diary, return of the used sachet during the follow up visits) Patients on anti-oxidants, traditional medications or herbal products for the last 3 months Topical usage of steroids, systemic steroids and non-steroidal anti-inflammatory drugs.
- Sepsis Compliance less than 75%.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Azhany Yaakub, MD, MMed, PhD contact
Malaysia4 sites, 4 recruiting
- Recruiting
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586
Munira Yusoff, Masters of Ophthamology, +60139812116, drmyusoff@gmail.com
Thamarai Munirathinam, MD(Prague), +60177712935, nitaraicz88@gmail.com
- Recruiting
Hospital Sultan Ismail Petra
Kuala Krai, Kelantan, 18000
Norihan Ibrahim, Masters of Ophthamology, +60196610635, norihanibrahim13@gmail.com
Thamarai Munirathinam, MD(Prague), +60177712935, nitaraicz88@gmail.com
- Recruiting
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu, 20400
Anita Che Omar, Masters of Ophthamology, +60139221105, drnoranita@moh.gov.my
Thamarai Munirathinam, MD(Prague), +60177712935, nitaraicz88@gmail.com
- Recruiting
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Thamarai Munirathinam, Doctor of Medicine, +60177712935, nitaraicz88@gmail.com
Azhany Yaakub, MD (USM), MMed (Ophthal), PhD, azhany@usm.my
About this study
Official title: Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye.
The goal of this clinical trial is to evaluate the effects of stingless bee honey (Kelulut honey) in juvenile open-angle glaucoma patients. The study evaluates the effects on serum Interleukin 6 level(IL-6), retinal nerve fiber layer(RNFL) thickness and dry eye-related symptoms. A total of 60 participants who meet the study criteria will be randomly assigned to one of two groups. One group will consume 30 grams of Kelulut honey daily for a period of three months, while the control group will not receive honey or a placebo. Serum IL-6 level, RNFL thickness, Tear break up time (TBUT) and Schirmer Test 1 will be done before and after 90 days. Adherence to honey consumption will be monitored using a daily diary. This study aims to provide better understanding of the potential role of Kelulut honey as a supplementary therapy in patients with juvenile open-angle glaucoma.
Read the detailed description
This is a randomized clinical trial conducted at four centers in Malaysia to evaluate the effects of stingless bee honey (Kelulut honey) in patients with juvenile open-angle glaucoma (JOAG). The study aims to determine whether daily consumption of Kelulut honey affects blood inflammation levels, retinal nerve fiber layer thickness, and dry eye parameters.
Two centers are assigned to the honey treatment group, and the remaining two serve as the control "no-honey" group. Participants in the honey group will consume 30 grams of Kelulut honey daily for three months, provided in sachets. The control group will continue standard glaucoma care without honey. Compliance with honey consumption will be monitored using a printed diary. Participants who experience any allergic reaction will be advised to discontinue the honey immediately and seek medical attention.
Blood samples will be collected to measure serum interleukin-6 (IL-6) levels and transported under controlled conditions to the HUSM laboratory for analysis. All participants will undergo eye examinations including retinal nerve fiber layer imaging and assessments for dry eye disease, performed using standardized procedures before and after the 3-month intervention.
- Conditions
- Juvenile Open Angle Glaucoma, Dry Eye Disease (DED), Interleukin 6, Retinal Nerve Fiber Layer Thickness, HbA1c Level
- Being tested
- Stingless bee honey (Kelulut)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stingless bee honey (Kelulut)Biological
Also called Kelulut
Kelulut is stingless bee honey, a natural biologic product produced by stinglee bee species.
| Study group | Role | What they receive |
|---|---|---|
| Honey group | Active comparator | Subjects will be provided stingless bee honey packeted in sachets of 30g. They are required to consume 30gram of honey per day for a total of 90 days duration. Receives: Biological: Stingless bee honey (Kelulut) |
| Non-honey group | No intervention | Subjects in this group will not receive honey. Subjects will undergo comprehensive ophthalmic examination and blood taking for measurement of serum Interleukin-6 level before and after the duration of study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of serum Interleukin-6 level before and after consumption of stingless bee honey for 3 months among patients with juvenile open angle glaucoma
Blood taking will be done to evaluate any change in the level of interleukin -6
Measured: from the enrolment to the end of study at 90 days
serum Interleukin 6 level
Measurement of serum level of Interleukin-6
Measured: 90 days
Secondary outcomes (1)
Change in the retinal nerve fiber layer thickness before and after consumptio of stingless bee honey in patients with juvenile open angle glaucoma
Thickness of retinal nerve fiber layer is measured using Optical Coherence Tomography
Measured: From enrollment to the end of the treatment at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Jan 2026
- Primary completion15 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Open Angle GlaucomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan, Hospital Sultanah Nur Zahirah, Kuala Terengganu, Hospital Universiti Sains Malaysia
- Responsible party
- Principal investigator, Thamarai Munirathinam, Hospital Universiti Sains Malaysia
- Investigators
- Azhany Yaakub, MD, MMed, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396441
- Sponsor's protocol ID
- NMRR ID-25-00996-WFT
- Acronym
- HONEY-JOAG
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye.
- ClinicalTrials.gov ID
- NCT07396441
- Acronym / sponsor ID
- HONEY-JOAG / NMRR ID-25-00996-WFT
- Conditions
- Juvenile Open Angle Glaucoma, Dry Eye Disease (DED), Interleukin 6, Retinal Nerve Fiber Layer Thickness, HbA1c Level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan, Hospital Sultanah Nur Zahirah, Kuala Terengganu, Hospital Universiti Sains Malaysia
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Feb 2026 (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 evaluate the effects of stingless bee honey (Kelulut honey) in juvenile open-angle glaucoma patients. The study evaluates the effects on serum Interleukin 6 level(IL-6), retinal nerve fiber layer(RNFL) thickness and dry eye-related symptoms. A total of 60 participants who meet the study criteria will be randomly assigned to one of two groups. One group will consume 30 grams of Kelulut honey daily for a period of three months, while the control group will not receive honey or a placebo. Serum IL-6 level, RNFL thickness, Tear break up time (TBUT) and Schirmer Test 1 will be done before and after 90 days. Adherence to honey consumption will be monitored using a daily diary. This study aims to provide better understanding of the potential role of Kelulut honey as a supplementary therapy in patients with juvenile open-angle glaucoma.
Detailed description
This is a randomized clinical trial conducted at four centers in Malaysia to evaluate the effects of stingless bee honey (Kelulut honey) in patients with juvenile open-angle glaucoma (JOAG). The study aims to determine whether daily consumption of Kelulut honey affects blood inflammation levels, retinal nerve fiber layer thickness, and dry eye parameters.
Two centers are assigned to the honey treatment group, and the remaining two serve as the control "no-honey" group. Participants in the honey group will consume 30 grams of Kelulut honey daily for three months, provided in sachets. The control group will continue standard glaucoma care without honey. Compliance with honey consumption will be monitored using a printed diary. Participants who experience any allergic reaction will be advised to discontinue the honey immediately and seek medical attention.
Blood samples will be collected to measure serum interleukin-6 (IL-6) levels and transported under controlled conditions to the HUSM laboratory for analysis. All participants will undergo eye examinations including retinal nerve fiber layer imaging and assessments for dry eye disease, performed using standardized procedures before and after the 3-month intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honey group | Active comparator | Biological: Stingless bee honey (Kelulut)Subjects will be provided stingless bee honey packeted in sachets of 30g. They are required to consume 30gram of honey per day for a total of 90 days duration. |
| Non-honey group | No intervention | –Subjects in this group will not receive honey. Subjects will undergo comprehensive ophthalmic examination and blood taking for measurement of serum Interleukin-6 level before and after the duration of study. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- JOAG patients age 15 years old and above until 40 years old at the time of diagnosis Compliant to conventional treatment achieved target intraocular pressure
Key exclusion criteria (2 listed)
- Patients with allergy to honey or honey-based products OCT signal less than 6/10 Concurrent retinal diseases and other optic neuropathies Systemic neurodegenerative disease Systemic comorbidities such as diabetes mellitus and autoimmune diseases Patients on other honey-based products for the last 3 months Patient who consumes honey-based products during the study duration of 3 months (monitoring via honey-diary, return of the used sachet during the follow up visits) Patients on anti-oxidants, traditional medications or herbal products for the last 3 months Topical usage of steroids, systemic steroids and non-steroidal anti-inflammatory drugs.
- Sepsis Compliance less than 75%.
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 |
|---|---|---|
| Stingless bee honey (Kelulut)Also: KelulutKelulut is stingless bee honey, a natural biologic product produced by stinglee bee species. | Biological | Honey group |
Primary outcome
Change in the level of serum Interleukin-6 level before and after consumption of stingless bee honey for 3 months among patients with juvenile open angle glaucoma
Time frame: from the enrolment to the end of study at 90 days
Blood taking will be done to evaluate any change in the level of interleukin -6
serum Interleukin 6 level
Time frame: 90 days
Measurement of serum level of Interleukin-6
1 secondary outcome
Change in the retinal nerve fiber layer thickness before and after consumptio of stingless bee honey in patients with juvenile open angle glaucoma
Time frame: From enrollment to the end of the treatment at 90 days
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 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Juvenile Open Angle Glaucoma
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Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma
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.
Azhany Yaakub, MD, MMed, PhD contact
Azhany Yaakub, MD, MMed, PhD study director
Universiti Sains Malaysia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stingless bee honey (Kelulut) in people with Juvenile Open Angle Glaucoma and Dry Eye Disease (DED), run by Universiti Sains Malaysia at 4 sites 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 2 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thamarai Munirathinam, MD(Prague) (+60177712935, nitaraicz88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of serum Interleukin-6 level before and after consumption of stingless bee honey for 3 months among patients with juvenile open angle glaucoma (time frame: from the enrolment to the end of study at 90 days). The study lists 2 primary outcomes in all. 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 Feb 2026.