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| Name | Class |
|---|---|
| Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan | UNKNOWN |
| Hospital Sultanah Nur Zahirah, Kuala Terengganu | OTHER_GOV |
| Hospital Universiti Sains Malaysia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stingless bee honey (Kelulut) | Biological | Kelulut is stingless bee honey, a natural biologic product produced by stinglee bee species. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from the enrolment to the end of study at 90 days |
| serum Interleukin 6 level | Measurement of serum level of Interleukin-6 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of the treatment at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| change in the dry eye disease parameters | Tear break-up time and Schirmer test evaluation will be done on each subjects | From enrollment until the end of study at 90 days |
| Change in the level of glycated hemoglobin pre and post consumption of stingless honey kelulut |
Inclusion Criteria:
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
Exclusion Criteria:
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%.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thamarai Munirathinam, MD(Prague) | Contact | +60177712935 | nitaraicz88@gmail.com | |
| Azhany Yaakub, MD, MMed, PhD | Contact | azhany@usm.my |
| Name | Affiliation | Role |
|---|---|---|
| Azhany Yaakub, MD, MMed, PhD | Universiti Sains Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Raja Perempuan Zainab II | Recruiting | Kota Bharu | Kelantan | 15586 | Malaysia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jun 10, 2025 |
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Measurement of glycated hemoglobin will be done |
| From enrollment until the completion of study at 90 days |
| Hospital Sultan Ismail Petra | Recruiting | Kuala Krai | Kelantan | 18000 | Malaysia |
|
| Hospital Universiti Sains Malaysia | Recruiting | Kubang Kerian | Kelantan | 16150 | Malaysia |
|
| Hospital Sultanah Nur Zahirah | Recruiting | Kuala Terengganu | Terengganu | 20400 | Malaysia |
|
| Feb 3, 2026 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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