Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

NCT ID: NCT05009810

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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astaxanthin 4 mg

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

Group Type EXPERIMENTAL

astaxanthin 4 mg

Intervention Type DIETARY_SUPPLEMENT

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

astaxanthin 6 mg

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

Group Type EXPERIMENTAL

astaxanthin 6 mg

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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astaxanthin 4 mg

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

Intervention Type DIETARY_SUPPLEMENT

astaxanthin 6 mg

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EC2103320

Identifier Type: -

Identifier Source: org_study_id

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