Effects of Sea Buckthorn Oil on Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Symptom severity: symptom questionnaires and clinical dry eye tests
研究概览
简要总结
The objective is to study the effect of sea buckthorn oil on dry eye.
详细描述
The objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3 months. The dry eye symptoms will be monitored during the study using a validated questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood samples for the analyses of inflammatory markers are also obtained. The cytokine and other inflammation marker analyses are optional. The symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dry eye symptoms
排除标准
- •Severe illness
- •Anticholinergic drugs
研究组 & 干预措施
SB
Sea buckthorn oil group
干预措施: Sea buckthorn (Hippophaë rhamnoides) oil (Dietary Supplement)
PL
Placebo group
干预措施: Placebo comparison (Dietary Supplement)
结局指标
主要结局
Symptom severity: symptom questionnaires and clinical dry eye tests
时间窗: 3 months intervention + 1 month after the intervention
次要结局
- Tear film lipid profile, tear cytokines, inflammation mediators in blood(3 months intervention + 1 month after the intervention)
