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

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.

Study Overview

• Status: Recruiting
• Conditions: Interleukin 6; Dry Eye Disease (DED); Retinal Nerve Fiber Layer Thickness; HbA1c Level; Juvenile Open Angle Glaucoma
• Intervention / Treatment: Biological: Stingless bee honey (Kelulut)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thamarai Munirathinam, MD(Prague); Phone Number: +60177712935; Email: nitaraicz88@gmail.com
• Study Contact Backup: Name: Azhany Yaakub, MD, MMed, PhD; Email: azhany@usm.my

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Recruiting
      • Hospital Raja Perempuan Zainab Ii
      • Contact: Thamarai Munirathinam, MD(Prague); Phone Number: +60177712935; Email: nitaraicz88@gmail.com
      • Contact: Munira Yusoff, Masters of Ophthamology; Phone Number: +60139812116; Email: drmyusoff@gmail.com
    • Kuala Krai, Kelantan, Malaysia, 18000
      • Recruiting
      • Hospital Sultan Ismail Petra
      • Contact: Thamarai Munirathinam, MD(Prague); Phone Number: +60177712935; Email: nitaraicz88@gmail.com
      • Contact: Norihan Ibrahim, Masters of Ophthamology; Phone Number: +60196610635; Email: norihanibrahim13@gmail.com
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Recruiting
      • Hospital Universiti Sains Malaysia
      • Contact: Thamarai Munirathinam, Doctor of Medicine; Phone Number: +60177712935; Email: nitaraicz88@gmail.com
      • Contact: Azhany Yaakub, MD (USM), MMed (Ophthal), PhD; Email: azhany@usm.my
  • Terengganu
    • Kuala Terengganu, Terengganu, Malaysia, 20400
      • Recruiting
      • Hospital Sultanah Nur Zahirah
      • Contact: Thamarai Munirathinam, MD(Prague); Phone Number: +60177712935; Email: nitaraicz88@gmail.com
      • Contact: Anita Che Omar, Masters of Ophthamology; Phone Number: +60139221105; Email: drnoranita@moh.gov.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Honey group; 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); Kelulut is stingless bee honey, a natural biologic product produced by stinglee bee species.; Other Names: Kelulut
No Intervention: Non-honey group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	Measurement of glycated hemoglobin will be done	From enrollment until the completion of study at 90 days

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: Hospital Universiti Sains Malaysia; Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan; Hospital Sultanah Nur Zahirah, Kuala Terengganu
• Investigators: Study Director: Azhany Yaakub, MD, MMed, PhD, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: NMRR ID-25-00996-WFT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No