Omegia Softgel Clinical Research Program

NCT ID: NCT05872178

Last Updated: 2023-05-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-12-31

Brief Summary

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Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel

Detailed Description

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The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density lipoprotein- Cholesterol.

The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin collagen content.

Conditions

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Skin Manifestations Antioxidative Stress Eye Strain Vaginal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omegia® Softgel -A

Take Omegia® Softgel -A once a day for 12 weeks

Group Type PLACEBO_COMPARATOR

Omegia® Softgel -A

Intervention Type DIETARY_SUPPLEMENT

How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.

Omegia® Softgel -B

Take Omegia® Softgel-B once a day for 12 weeks

Group Type EXPERIMENTAL

Omegia® Softgel -B

Intervention Type DIETARY_SUPPLEMENT

How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.

Interventions

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Omegia® Softgel -B

How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.

Intervention Type DIETARY_SUPPLEMENT

Omegia® Softgel -A

How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

● Female subjects older than 45 years

Exclusion Criteria

* Involuntary subjects
* Skin disease, liver cirrhosis or chronic renal failure
* Those with known cosmetic, drug or food allergies
* Pregnant women and nursing mothers.
* Those taking chronic disease medication
* The subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chia Nan University of Pharmacy & Science

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chia Nan University of Pharmacy & Science

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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Gold MH, Goldman MP, Biron J. Efficacy of novel skin cream containing mixture of human growth factors and cytokines for skin rejuvenation. J Drugs Dermatol. 2007 Feb;6(2):197-201.

Reference Type BACKGROUND
PMID: 17373178 (View on PubMed)

Rodrigues F, Sarmento B, Amaral MH, Oliveira MB. Exploring the antioxidant potentiality of two food by-products into a topical cream: stability, in vitro and in vivo evaluation. Drug Dev Ind Pharm. 2016;42(6):880-9. doi: 10.3109/03639045.2015.1088865. Epub 2015 Sep 22.

Reference Type BACKGROUND
PMID: 26393899 (View on PubMed)

Other Identifiers

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TSMHIRB-2-029-2.2

Identifier Type: -

Identifier Source: org_study_id

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