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Effects of an Oral Herbal Supplement on Skin Aging, Hydration, and Elasticity

NCT ID: NCT06146140

Last Updated: 2023-11-24

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-01

Brief Summary

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The purpose of this study is to evaluate how an oral herbal supplementation influences facial skin elasticity and facial hydration as well as markers of photoaging (erythema and pigmentation).

Detailed Description

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Skin is the largest organ of the body and skin aging represents a primary indicator of the aging process in the body. Photoaging is among the most crucial factors that cause skin aging damage. Photoaged skin is primarily induced by prolonged exposure to ultraviolet radiation leading to the appearance of increased skin pigmentation, reduced elasticity, and pronounced wrinkles. There has been an increasing recognition of the influence of nutrition on skin health with dietary elements emerging as a viable alternative approach to preventing photoaging. The aim of this study is to understand how oral supplementation impacts photoaged skin, facial hydration, and facial elasticity.

Conditions

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Photoaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oral Herbal Supplement

Oral supplement containing an herbal blend

Group Type EXPERIMENTAL

Oral herbal supplement

Intervention Type DIETARY_SUPPLEMENT

Take one capsule daily

Oral Placebo Supplement

Oral placebo supplement

Group Type PLACEBO_COMPARATOR

Oral placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Take one capsule daily

Interventions

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Oral herbal supplement

Take one capsule daily

Intervention Type DIETARY_SUPPLEMENT

Oral placebo supplement

Take one capsule daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\- Women who are 35 to 55 years of age

Exclusion Criteria

* Individuals who are pregnant or breastfeeding.
* Prisoners.
* Adults unable to consent.
* Those who are unwilling to discontinue topical probiotics, topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
* Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
* Any known allergy to any of the ingredients in the study product.
* Those who have been on an oral antibiotic within 1 month prior enrolling
* Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vidya Herbs

UNKNOWN

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Laila Afzal

Role: CONTACT

[email protected]
916-524-1216

Nasima Afzal

Role: CONTACT

[email protected]
916-524-1216

Other Identifiers

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i23-09-Vidya_Skin_Supp

Identifier Type: -

Identifier Source: org_study_id