Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
- Conditions
- Hair Damage
- Interventions
- Dietary Supplement: Keranat™Dietary Supplement: placebo
- Registration Number
- NCT06237959
- Lead Sponsor
- Nutracore
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Keranat™ Keranat™ Keranat™ capsule will be administered orally twice daily for 24 weeks. Placebo placebo Placebo capsule will be administered orally twice daily for 24 weeks.
- Primary Outcome Measures
Name Time Method The change of hair elasticity 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.The change of hair gloss 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.
- Secondary Outcome Measures
Name Time Method The change of anagen hair ratio(%) 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.
The change of serum levels of cytokines (IL-1, TNF-α, PGE2) 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.
The change of hair thickness 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.
The change of number of hair per unit area 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.
The change in hair loss amount 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.
The change of hair distribution score through clinical photography 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.
Self-reported Hair health assessments 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.
Trial Locations
- Locations (1)
KSRC Korean Skin Research Center
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of