CTRI/2023/08/057023Other2/3 期
A Double-Blind, Placebo-Controlled Trial on the Effects of Lutein and Zeaxanthinon Macular pigment optical density response, Photo stress Recovery, GlareDisability, and Chromatic Contrast
Star Hi Herbs PvtLtd1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月9日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- Other
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Change in macular pigment optical density (MPOD)
研究概览
简要总结
The clinical study has been terminated based on the sponsor decision. We also confirm that the principal investigator has neither screened nor enrolled any subjects for this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged 20 to 65 years old
- •BMI: 20 to 30kg/m2
- •Corrected eyesight is higher than 20/60 during eyesight testing (corrected visual acuity)
- •The subjects who have MPOD level between 0.2to 0.4 and those without any severe eye diseases.
- •The subjects who doesn’t have any problem on eye accommodation
- •The subjects who has drusen corresponding to early AMD (category 2) of AREDS
- •Subjects willing to comply with the prescribed treatment regimen for the duration of study participation.
- •No Known metabolic diseases or gastrointestina disorders and no known cognitive decline
- •No anticipated changes in dieting habits (as relevant to xanthophyll intake).
- •Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
- •The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements.
排除标准
- •Subjects with the complete vision loss
- •Subjects who are allergic to the study drug
- •Subjects suffering from severe or uncontrolled systemic or metabolic diseases.
- •Pregnant, lactating woman, or planning to become prenant.
- •Subjects who are taking any other medicine which interact with the study drug during the treatment
- •Subjects with severe concurrent illness (cardiovascular, renal, hepatic), and with any other condition that in the opinion of the investigator does not justify the inclusion of the subject in the study.
- •Subject whose lifestyle (including diet and food intake) would, in the Investigator’s judgment affect the subject’s participation in the study.
- •Subjects who have participated in any other clinical trial in the past 30 days from the study start.
- •Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
- •Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
- •Ophthalmic patients other than AMD, retinal surgery and retinal laser treatment
- •Subjects with macular atrophy
- •Those with signs of exudative changes, including subretinal retinal fluid, pigmented epithelial detachment or bleeding
- •Subjects with 6 diopter and above myopia factors
- •Subjects with a cloudy cataract or cornea
- •Current use of xanthophyll containing supplements
- •Use of xanthophyll containing supplements in the past 6 months
- •Blood donation during the last 3 months.
- •Known hypersensitivity or allergy to xanthophylls.
- •Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
- •Suspected lack of compliance with any requirements of the study.
- •Any relevant abnormalities in the routine laboratory tests
- •Alcoholics
- •The subjects who are already undergoing the medications such as Lutein, Zeaxanthin, Omega3
- •The subjects taking the products of Functional ingredients that may help to eye health such as Bilberry extract, Haematococcus extract, Zeaxanthin extract, Lutein compound.
结局指标
主要结局
1. Change in macular pigment optical density (MPOD)
时间窗: 1. Change in macular pigment optical density (MPOD) at Day 1, Day 90, 180. | 2. Lutein & Zeaxanthin amount in the blood at Day 0, Day 90, Day 180
2. Lutein & Zeaxanthin amount in the blood
时间窗: 1. Change in macular pigment optical density (MPOD) at Day 1, Day 90, 180. | 2. Lutein & Zeaxanthin amount in the blood at Day 0, Day 90, Day 180
次要结局
- 1. Change in glare disability & discomfort(2. Change in speeding photo stress recovery)
研究者
研究点 (1)
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