Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 主要终点
- Intra-ocular pressure
研究概览
简要总结
Cordyceps cicadae mycelia was tested for amelioration of dry eye symptoms through dietary supplementation. Its efficacy in relief of human dry eye status was assessed by randomized, double-blinded tests, including multiple assessments. The results were compared between the placebo group and the experimental group.
详细描述
Former animal studies had shown that Cordyceps cicadae mycelia can effectively ameliorate UVB-induced dry eye symptoms. This study further investigated its efficacy in human dry eye status by randomized, double-blinded tests, including dry eye questionnaires, blood tests, salivary tests, tear volume test, intra-ocular pressure assessments, ocular surface photography, corneal fluorescein stain, tear film breakup time test, fundus photography, and cornea impression cytology. All tests were performed again after 3 months of dietary supplement of either samples or placebo. A total of 97 participants completed the trial. The data were analyzed by paired-t test and compared between the placebo and the experimental groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.
排除标准
- •Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.
研究组 & 干预措施
Experimental group
supplement was given for 3 months.
干预措施: Cordyceps Cicadae Mycelia (Dietary Supplement)
Placebo group
Placebo was given for 3 months.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Intra-ocular pressure
时间窗: day 1 to day 90.
Intra-ocular pressure was taken to assess eye pressure.
tear film breakup time
时间窗: day 1 to day 90.
Tear film breakup time was used for tear quality assessments.
Cornea surface scores based on Efron grading system
时间窗: day 1 to day 90.
Cornea surface scores based on Efron grading system was used for assessment of cornea surface damages.
次要结局
未报告次要终点
研究者
David Pei-Cheng Lin
Professor
Chung Shan Medical University