Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health

NCT ID: NCT06237959

Last Updated: 2024-02-02

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2023-12-11

Brief Summary

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The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss.

Detailed Description

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Conditions

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Hair Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Keranat™

Keranat™ capsule will be administered orally twice daily for 24 weeks.

Group Type EXPERIMENTAL

Keranat™

Intervention Type DIETARY_SUPPLEMENT

300 mg/capsule(proso millet and wheat extract 600 mg/day)

Placebo

Placebo capsule will be administered orally twice daily for 24 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

300 mg/capsule(600 mg/day as placebo)

Interventions

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Keranat™

300 mg/capsule(proso millet and wheat extract 600 mg/day)

Intervention Type DIETARY_SUPPLEMENT

placebo

300 mg/capsule(600 mg/day as placebo)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 19 and 60
* Hair gloss score of 3 or less and a hair damage score of less than 18 according to the visual evaluation classification method.
* Willing to maintain the same hairstyle, hair color, hair length, and hair regimen throughout the study period.
* Subject must be able to comprehend and voluntarily sign study procedures and consent forms.

Exclusion Criteria

* Those diagnosed with and receiving treatment for the alopecia within 3 months before screening(androgenetic alopecia, alopecia areata, Telogen effluvium, etc.)
* Use of that may affect hair or hair loss symptoms treatment medicine, dietary supplements, or treatments containing herbal medicine ingredients within 3 months before screening.
* Any active scalp or skin disease that may interfere with the study treatment and evaluations.
* Pregnancy or breastfeeding or planning pregnancy
* Case of abnormal values at creatinine (excess at the upper limit of the reference range)
* Case of abnormal values at ALT or AST (2 times excess at the upper limit of the reference range)
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novarex

UNKNOWN

Sponsor Role collaborator

Nutracore

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KSRC Korean Skin Research Center

Seongnam-si, Gyeonggido, South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NC07-NOVA-2022

Identifier Type: -

Identifier Source: org_study_id

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