Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07396441

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Stingless bee honey (Kelulut)

Biological

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

Other names: Kelulut

Primary outcomes

  1. 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

  2. serum Interleukin 6 level

    Time frame: 90 days

    Measurement of serum level of Interleukin-6

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

    Time frame: From enrollment to the end of the treatment at 90 days

    Thickness of retinal nerve fiber layer is measured using Optical Coherence Tomography

Other outcomes

  1. change in the dry eye disease parameters

    Time frame: From enrollment until the end of study at 90 days

    Tear break-up time and Schirmer test evaluation will be done on each subjects

  2. Change in the level of glycated hemoglobin pre and post consumption of stingless honey kelulut

    Time frame: From enrollment until the completion of study at 90 days

    Measurement of glycated hemoglobin will be done

Study contacts

Contact information is provided by the study sponsor or research team.

Azhany Yaakub, MD, MMed, PhD

CONTACT

[email protected]

Thamarai Munirathinam, MD(Prague)

CONTACT

[email protected]

+60177712935

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HONEY-JOAG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.