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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Stingless bee honey (Kelulut)
  Kelulut is stingless bee honey, a natural biologic product produced by stinglee bee species.

Первичные конечные точки

• 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 [Срок оценки: from the enrolment to the end of study at 90 days]
• serum Interleukin 6 level [Срок оценки: 90 days]

Вторичные конечные точки (1)

• Change in the retinal nerve fiber layer thickness before and after consumptio of stingless bee honey in patients with juvenile open angle glaucoma [Срок оценки: From enrollment to the end of the treatment at 90 days]

Критерии участия

Критерии включения

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

Критерии исключения

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%.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 4 центра

• Hospital Raja Perempuan Zainab II — Kota Bharu
• Hospital Sultan Ismail Petra — Kuala Krai
• Hospital Universiti Sains Malaysia — Kubang Kerian
• Hospital Sultanah Nur Zahirah — Kuala Terengganu

Идентификаторы

NCT: NCT07396441 · NMRR ID-25-00996-WFT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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