Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Chulalongkorn University180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

180

Conditions

Refractive Errors

Interventions

astaxanthin 4 mgDIETARY_SUPPLEMENT

They will take astaxanthin 4 mg 1 capsule once daily for 2 months.

astaxanthin 6 mgDIETARY_SUPPLEMENT

They will take astaxanthin 6 mg 1 capsule once daily for 2 months.

PlaceboDIETARY_SUPPLEMENT

They will take placebo 1 capsule once daily for 2 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-65 years * Refraction errors, dry eye, or blurred vision * Have a willingness to participate in the study Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Visual acuity value

Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)

Time frame: 2 months

Secondary Outcomes

Refractive status

Measured using Auto refractometer (two digit scale)

Time frame: 2 months

Eye fatigue status

Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5))

Time frame: 2 months

Vision status

Measured using Thai National Eye Institute Visual Functioning Questionnaire 25 (scale 25 to 100 which are normal (25) to worse(100))

Time frame: 2 months

Skin erythema value

Measured using Mexameter (skin erythema index)

Time frame: 2 months

Skin melanin value

Measured using Mexameter (skin melanin index)

Time frame: 2 months

Skin humidity value

Measured using Corneometer (skin humidity index)

Time frame: 2 months

Skin transepidermal water loss value

Measured using Transepidermal water loss meter (skin transepidermal water loss index)

Time frame: 2 months

Aspartate transaminase value

Data from ClinicalTrials.gov

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