A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes of Ocular Surface Disease Index
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 46 subjects were randomly divided into Hydrolysed Red Ginseng extract 10ml or placebo group. The investigators measured Ocular Surface Disease Index, tear break-up time, Visual analog scale, Schirmer's test, meibomian gland test and Fluorescein staining.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and women over 19years
- •Ocular Surface Disease Index score is 13 scores and more at a screening
- •Tear Break-Up Time is 10 seconds less or those who have positive in ocular staining test at a screening
- •After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
排除标准
- •Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
- •Those who have clinically significant acute or chronic ophthalmologic, cardiovascular system, endocrine, immune, respiratory, liver biliary system, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- •Those who couldn't control diabetes at screening
- •Those with acute eye infections or inflammation within 1 month before screening
- •Those who have ophthalmic surgery within 3 months before screening
- •Those who use contact lens 1 month before screening
- •Those who take a medication or health function food that affects your promotion of dry eye within 1 month prior to the screening
- •Those who have received antipsychotic medication within 3 months before screening
- •Those who alcoholic or drug abuse suspected
- •Those who participated in other clinical trials within 3 months before screening
- •Laboratory test by showing the following results
- •Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dL
- •Pregnancy or breastfeeding
- •Those who don't accept the implementation of appropriate contraception of a childbearing woman
- •Principal Investigator judged inappropriate for participation in the study because of Laboratory test results, etc.
结局指标
主要结局
Changes of Ocular Surface Disease Index
时间窗: 12 weeks
A questionnaire which is Ocular Surface Disease Index consisted of 12 questions each of which included visual symptoms, visual work status, and environmental factors. The Ocular Surface Disease Index scores are ranged from 0 to 100, and the high score is the more severe the symptoms. The Ocular Surface Disease Index score is calculated as follows. : (Sum of all items answered × 25) / total number of questions answered
Changes of tear break-up time
时间窗: 12 weeks
The tear break-up time test measures the time in seconds. The time is from the last blinking to the point of tear layer defect or streak-like defect after blinking the eye with 1% of fluorescein. 10 seconds or more as normal, between 5 and 10 seconds as mild dry eye syndrome, and 5 seconds or less as severe dry eye syndrome.
次要结局
- Changes of Fluorescein staining(12 weeks)
- Changes of Visual analog scale(12 weeks)
- Changes of Schirmer's test(12 weeks)
- Changes of meibomian gland test(12 weeks)
研究者
You, In Cheon
Professor of ophthalmology
Chonbuk National University Hospital