NCT07396441 Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye
| NCT ID | NCT07396441 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universiti Sains Malaysia |
| Condition | Juvenile Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2026-01-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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%.
Contact & Investigator
Azhany Yaakub, MD, MMed, PhD
STUDY DIRECTOR
Universiti Sains Malaysia
Frequently Asked Questions
Who can join the NCT07396441 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 40 Years, studying Juvenile Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07396441 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07396441 currently recruiting?
Yes, NCT07396441 is actively recruiting participants. Contact the research team at nitaraicz88@gmail.com for enrollment information.
Where is the NCT07396441 trial being conducted?
This trial is being conducted at Kota Bharu, Malaysia, Kuala Krai, Malaysia, Kubang Kerian, Malaysia, Kuala Terengganu, Malaysia.
Who is sponsoring the NCT07396441 clinical trial?
NCT07396441 is sponsored by Universiti Sains Malaysia. The principal investigator is Azhany Yaakub, MD, MMed, PhD at Universiti Sains Malaysia. The trial plans to enroll 60 participants.