Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441 | Recruiting Phase 4

• 1 other identifier: NMRR ID-25-00996-WFT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Juvenile Open Angle Glaucoma; Dry Eye Disease (DED); Interleukin 6; Retinal Nerve Fiber Layer Thickness; HbA1c Level

Outcome Measures

Primary Outcomes (2)

• 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

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

  From enrollment to the end of the treatment at 90 days

Other Outcomes (2)

• change in the dry eye disease parameters

  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

  From enrollment until the completion of study at 90 days

Study Arms (2)

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.

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.

Interventions

Stingless bee honey (Kelulut) BIOLOGICAL

Kelulut is stingless bee honey, a natural biologic product produced by stinglee bee species.

Also known as: Kelulut

Honey group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan: collaborator
• Hospital Sultanah Nur Zahirah, Kuala Terengganu: collaborator
• Hospital Universiti Sains Malaysia: collaborator

Study Sites (4)

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

RECRUITING

Hospital Sultan Ismail Petra

Kuala Krai, Kelantan, 18000, Malaysia

RECRUITING

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, 20400, Malaysia

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Azhany Yaakub, MD, MMed, PhD

  Universiti Sains Malaysia

  STUDY DIRECTOR

Central Study Contacts

Thamarai Munirathinam, MD(Prague)

CONTACT

+60177712935; nitaraicz88@gmail.com

Azhany Yaakub, MD, MMed, PhD

CONTACT

azhany@usm.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine (MD), Medical Officer, Prinicipal Investigator, Department of Ophthalmology,

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 9, 2026
• Study Start: January 15, 2026
• Primary Completion: May 15, 2026
• Study Completion: June 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)