Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms

Официальное название

A Randomized Controlled Trial on the Effects of Oral Kelulut Honey Supplementation on Conjunctival Goblet Cell Density, Tear Film Stability, Dry Eye Disease Symptoms and Vision-Related Function in Patients With Allergic Conjunctivitis

Обзор

The goal of this clinical trial is to learn if oral Kelulut honey works to improve eye symptoms in adults with allergic conjunctivitis. It will also look at how safe Kelulut honey is when taken as a daily supplement. The main questions it aims to answer are: 1. Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis? 2. Does oral Kelulut honey improve tear film stability and the health of conjunctival goblet cells (special cells on the eye surface that help keep the eye moist)? 3. What side effects or medical problems do participants have when taking Kelulut honey? Researchers will compare oral Kelulut honey to a honey-flavoured placebo syrup (a look-alike drink that does not contain Kelulut honey) to see if Kelulut honey is more effective than placebo for treating eye symptoms in allergic conjunctivitis. Participants will: 1. Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month 2. Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor 3. Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health 4. Answer questionnaires about their eye symptoms and how these affect their daily activities and vision-related quality of life Participation is voluntary, and participants may stop taking part in the study at any time. Data collected up to the time they withdraw may still be used for research, but their routine medical care will not be affected

Вмешательства

• Пищевая добавка Kelulut Honey 60 g Oral Supplement
  Participants in this arm will consume two 30 g sachets of Kelulut honey once daily (total 60 g/day) for one month. The honey will be taken directly from the sachet without dilution, on an empty stomach, 30 minutes before breakfast. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.
• Пищевая добавка Kelulut Honey 120 g Oral Supplement
  Participants in this arm will consume four 30 g sachets of Kelulut honey daily (total 120 g/day) for one month. The daily dose will be divided into two administrations: two sachets before breakfast or lunch, and two sachets before dinner. The honey will be taken directly from the sachets without dilution, at least 30 minutes before meals. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.
• Другое Honey-Flavoured Zero-Calorie Syrup (Placebo)
  Participants in this placebo group will receive honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to those used for the Kelulut honey. Each participant will consume two sachets per day, to be taken daily, once before breakfast, for one month duration. The syrup is to be taken directly from the sachets, without dilution, before meals.

Первичные конечные точки

• Change in conjunctival goblet cell density (GCD) [Срок оценки: Baseline and 1 month]

Вторичные конечные точки (3)

• Change in tear film break-up time (TBUT) [Срок оценки: Baseline and 1 month]
• Change in ocular surface staining score (OGS) [Срок оценки: Baseline and 1 month]
• Change in Ocular Surface Disease Index (OSDI) score [Срок оценки: Baseline and 1 month]

Критерии участия

Критерии включения

i. Age between 18-40 years old ii. Confirmed diagnosis of allergic conjunctivits iii. Ocular surface disease index (OSDI) score > 12 iv. Compliance to conventional allergic conjunctivitis treatment

Критерии исключения

i. Any corneal or ocular surface pathology ii. Known diabetes mellitus or impaired glucose test iii. Ocular surface disease due to trachoma or other inflammatory conditions iv. Consume anti-inflammatory medications such as steroids, NSAIDS, oral doxycycline v. Concurrent use of other supplements or alternative therapies such as royal jelly, Manuka honey eye drop or omega-3 fatty acid vi. Using preservative-containing topical eye drops for ocular problems other than AC, such as anti-glaucoma medication vii. History of ocular trauma/surgery or refractive surgery within last 3 years viii. Wearing contact lens in the last 3 months ix. Underlying inflammatory/ systemic disease and connective tissue diseases x. Recent conjunctivitis in the last 3 months xi. Patients on immunosuppressant

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

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Малайзия · 1 центр

• Hospital Pakar Universiti Sains Malaysia — Kota Bharu

Идентификаторы

NCT: NCT07273747 · USM/JEPeM/KK/24080659

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗