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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in conjunctival goblet cell density (GCD)
研究概览
简要总结
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:
- Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis?
- 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)?
- 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:
- Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month
- Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor
- Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in conjunctival goblet cell density (GCD)
时间窗: Baseline and 1 month
Goblet cell density measured via impression cytology and quantified using standard morphological grading. Change from baseline to 1 month will be compared between groups.
次要结局
- Change in tear film break-up time (TBUT)(Baseline and 1 month)
- Change in ocular surface staining score (OGS)(Baseline and 1 month)
- Change in Ocular Surface Disease Index (OSDI) score(Baseline and 1 month)
研究者
Shahidatul Adha Mohamad
Dr.
Universiti Sains Malaysia