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

January 24, 2024 updated by: Nutracore

A 24-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 11234
        • KSRC Korean Skin Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Keranat™
Keranat™ capsule will be administered orally twice daily for 24 weeks.
Dietary supplement: Keranat™
300 mg/capsule(proso millet and wheat extract 600 mg/day)
Placebo Comparator: Placebo
Placebo capsule will be administered orally twice daily for 24 weeks.
Dietary supplement: placebo
300 mg/capsule(600 mg/day as placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of hair elasticity
Time Frame: Change of the week 24 from baseline

To evaluate the change in hair elasticity between the Keranat™ and placebo group.

Hair elasticity was measured using an Expert 7601Tension Testing System.
Change of the week 24 from baseline
The change of hair gloss
Time Frame: Change of the week 24 from baseline
To evaluate the change in hair gloss between the Keranat™ and placebo group. Hair gloss was measured using a Skin-Glossy meter GL200.
Change of the week 24 from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of hair thickness
Time Frame: Change of the week 24 from baseline
To evaluate the change in hair thickness improvement between the Keranat™ and placebo group. Hair thinness was assessed by measuring hair diameter using a microscope and ToupLite software.
Change of the week 24 from baseline
The change of anagen hair ratio(%)
Time Frame: Change of the week 24 from baseline
To evaluate the change in the ratio of anagen hair between the Keranat™ and placebo group. Changes in Hair growth that occurred in the hair removal area for 3 days were analyzed using the Image-Pro® 10 program.
Change of the week 24 from baseline
The change in hair loss amount
Time Frame: Change of the week 24 from baseline
To evaluate the change in the number of hair loss between the Keranat™ and placebo group. Collected and counted the number of lost hair.
Change of the week 24 from baseline
The change of number of hair per unit area
Time Frame: Change of the week 24 from baseline
To evaluate the change in the number of hairs per unit area between the Keranat™ and placebo group. The number of hairs per unit area of the hair removal area was counted using Folliscope PS.
Change of the week 24 from baseline
The change of hair distribution score through clinical photography
Time Frame: Change of the week 24 from baseline
To evaluate the change in hair distribution score through clinical photography between the Keranat™ and placebo group before and after intake. This evaluates improvement and deterioration on a 7-point scale, with higher scores meaning improvement. By comparing photos before and after intake, if there is no change, 0 points, improvement is a maximum of 3 points, and worsening is a minimum of -3 points.
Change of the week 24 from baseline
Self-reported Hair health assessments
Time Frame: Change of the week 24 from baseline
To evaluate the change in Hair health improvement between the Keranat™ and placebo group. The evaluation was conducted through Patient Report Outcome(PRO) using a standardized survey form. Survey allowing for participant-report changes in hair health as a result of intervention using a 7-point scale.
Change of the week 24 from baseline
The change of serum levels of cytokines (IL-1, TNF-α, PGE2)
Time Frame: Change of the week 24 from baseline
To evaluate the change in serum levels of cytokines through clinical photography between the Keranat™ and placebo group.
Change of the week 24 from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutracore

Collaborators

Novarex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Actual)

June 12, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NC07-NOVA-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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