The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- change from tear break-up time(seconds)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.
详细描述
In this double-blind, randomized and placebo-controlled trial, twenty participants experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of either ZSO or soy bean oil (SBO) as placebo for 10 weeks. All participants completed the study. Follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress markers, and blood lipid analysis were performed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women
- •20 to 70 years with dry eye disease
- •low tear break-up time (TBUT) (<10 seconds) or low Schirmer score (with application of local anesthetic) (<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening.
- •blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively.
排除标准
- •under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin)
- •hypolipidemic medication within 3 months of study entry
- •history of chronic disease
- •any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study
- •allergic or hypersensitive to any of the ingredients in the test products.
- •women who were pregnant or breast feeding
- •a history of alcoholism or drug abuse or medical or psychological conditions
研究组 & 干预措施
Zanthoxylum schinifolium seed Oil
Zanthoxylum schinifolium seed Oil 100% (4g/day)
干预措施: Zanthoxylum Schinifolium Seed Oil(4g/day) (Dietary Supplement)
soy bean oil
soy bean oil 99.9%, edible dyes 0.01% (4g/day)
干预措施: Soy Bean Oil;placebo(4g/day) (Dietary Supplement)
结局指标
主要结局
change from tear break-up time(seconds)
时间窗: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week
change from Schirmer test(mm)
时间窗: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week intervention period
change from corneal staining(0 to 5 grade)
时间窗: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week
change from ocular surface disease index(0 to 100 score)
时间窗: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-weeks and 10-weeks
次要结局
- change from total cholesterol(mg/dL)(baseline, 10 weeks)
- change from triglyceride(mg/dL)(baseline, 10 weeks)
- change from low-density lipoprotein cholesterol(mg/dL)(baseline, 10 weeks)
- change from interferon-gamma(pg/mL)(baseline, 10 weeks)
- change from malondialdehyde(nU/L)(baseline, 10 weeks)
- change from interleukin-13(pg/mL)(baseline, 10 weeks)
- change from interleukin-17(pg/mL)(baseline, 10 weeks)
- change from low-density lipoprotein(pmol/mg)(baseline, 10 weeks)
- change from interleukin-1β(pg/mL)(baseline, 10 weeks)
- change from high-density lipoprotein cholesterol(mg/dL)(baseline, 10 weeks)
研究者
Soo-Wan Chae
M.D., Ph.D.
Chonbuk National University Hospital