The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Choroidal Thickness(micrometer)
研究概览
简要总结
Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal thickness of the young participant using SD-OCT to see the effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness.
详细描述
34 young, healthy participants were included in this study; They were randomly divided into two groups by age and gender matched.100 mg Longevinex® capsule was given to the study group and 100mg placebo capsule to the control group. All participants underwent OCT scanning with spectral domain optic coherence tomography (SD-OCT) at baseline and 1 h following Longevinex® or placebo administration. The choroidal thickness was measured manually by the Heidelberg Eye explore software(version 5.3.3.0, Heidelberg Engineering) with a vertical line to the retinal pigment epithelial layer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 23 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients 23-28 years of age. nonsmokers.
- •Patients were considered to be healthy on the basis of electrocardiogram (ECG), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis B, hepatitis C and HIV serology) performed at screening.
- •Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time.
- •patients should abstain from alcohol-containing beverages at least two days prior to and during the study.
排除标准
- •Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
- •Participation in another simultaneous medical investigation or trial Renal failure requiring dialysis or renal transplant or liver dysfunction History of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.
- •IOP over 30 mmHg.
- •Any previous retinal laser photocoagulation to the study eye in treatment naive. Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
- •Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery).
- •Intracapsular cataract extraction (posterior capsule needs to be present).
- •Aphakia or absence of the posterior capsule in the study eye, Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s).
研究组 & 干预措施
LONGEVINEX
The Effect of LONGEVINEX on Choroidal Thickness
干预措施: LONGEVINEX (Drug)
placebo
The Effect of placebo on Choroidal Thickness
干预措施: placebo (Drug)
结局指标
主要结局
Choroidal Thickness(micrometer)
时间窗: baseline
using Heidelberg Eye Explorer software to measure choroidal thickness of participants
次要结局
- Choroidal Thickness(micrometer)(1 hour after baseline)
研究者
Xufang Sun
study director
Huazhong University of Science and Technology