Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Chulalongkorn University

Status: Unknown

Conditions: Refractive Errors

Treatments: Dietary Supplement: astaxanthin 4 mg; Dietary Supplement: astaxanthin 6 mg; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05009810

EC2103320

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

astaxanthin 4 mg

Experimental group

Description:

The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months.

Treatment:

Dietary Supplement: astaxanthin 4 mg

astaxanthin 6 mg

Experimental group

Description:

The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months.

Treatment:

Dietary Supplement: astaxanthin 6 mg

Placebo

Placebo Comparator group

Description:

The placebo will be taken 1 capsule once daily for 2 months.

Treatment:

Dietary Supplement: Placebo