NCT06237959已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nutracore
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The change of hair elasticity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
The change of hair elasticity
时间窗: 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
时间窗: 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.
次要结局
- The change of anagen hair ratio(%)(Change of the week 24 from baseline)
- The change of serum levels of cytokines (IL-1, TNF-α, PGE2)(Change of the week 24 from baseline)
- The change of hair thickness(Change of the week 24 from baseline)
- The change of number of hair per unit area(Change of the week 24 from baseline)
- The change in hair loss amount(Change of the week 24 from baseline)
- The change of hair distribution score through clinical photography(Change of the week 24 from baseline)
- Self-reported Hair health assessments(Change of the week 24 from baseline)
研究者
研究点 (2)
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