Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 主要终点
- Visual acuity value
研究概览
简要总结
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking astaxanthin for 1 and 2 months.
详细描述
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. They will divided into 3 groups which are astaxanthin 4 mg group , astaxanthin 6 mg group, and placebo group. They will take the sample 1 capsule once daily for 2 months. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking the sample for 1 and 2 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Refraction errors, dry eye, or blurred vision
- •Have a willingness to participate in the study
排除标准
- •Uncontrolled disease
- •Have complications during the study
- •Have astaxanthin more than 2 weeks
- •Allergic to astaxanthin, seafood, or seaweed
- •Osteoporosis or thyroid disease
- •Immunodeficiency or taking immunosuppressants
- •Liver and kidney diseases
- •A person with a brain disorder, vision or hearing unusual
- •Pregnancy or lactation
- •Cannot follow the protocol
- •During participated in other studies
研究组 & 干预措施
astaxanthin 4 mg
The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months.
干预措施: astaxanthin 4 mg (Dietary Supplement)
astaxanthin 6 mg
The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months.
干预措施: astaxanthin 6 mg (Dietary Supplement)
Placebo
The placebo will be taken 1 capsule once daily for 2 months.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Visual acuity value
时间窗: 2 months
Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)
次要结局
- Skin humidity value(2 months)
- Alanine aminotransferase value(2 months)
- Blood urea nitrogen value(2 months)
- Adverse events(2 months)
- Refractive status(2 months)
- Eye fatigue status(2 months)
- Skin transepidermal water loss value(2 months)
- Alkaline phosphatase value(2 months)
- Vision status(2 months)
- Skin erythema value(2 months)
- Skin melanin value(2 months)
- Aspartate transaminase value(2 months)
- Creatinine value(2 months)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University