A Randomized, Double Blind, Placebo Controlled, Parallel Human Study for the Evaluation of the Efficacy and Safety of FHH-MG on Hair Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel clinical trial was conducted to evaluate the efficacy and safety of FHH-MG in adults with mild to moderate hair damage. After 24 weeks of intake, the FHH-MG group showed significant improvements compared with the placebo group in objective hair health parameters, including hair diameter, SEM hair gloss score, gloss meter value, hair density, scalp hydration, transepidermal water loss, hair tensile strength, and new hair root volume. No significant between-group difference was observed in subject satisfaction scores. Safety evaluation demonstrated that all reported adverse events were mild and unrelated to the investigational product, and no clinically significant changes were observed in physical examination, vital signs, or laboratory test results, confirming the safety of FHH-MG.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •Healthy male and female adults aged 19 to 60 years.
- •Subjects with mild to moderate hair damage (hair gloss score 1–3 and total hair damage score <18).
- •Subjects willing to refrain from chemical hair treatments (perm, dyeing, bleaching, hair clinic treatments, etc.) during the study.
- •Subjects who agree to maintain the same hairstyle throughout the study.
- •Subjects who voluntarily signed written informed consent.
排除标准
- •History of malignancy within the past 5 years.
- •Psychiatric disorders.
- •Infectious scalp diseases.
- •Hair loss disorders.
- •Clinically significant gastrointestinal, hepatobiliary, endocrine, hematologic, or gynecologic diseases.
- •History of hypersensitivity to the investigational product or tattoo ink used for hair assessment.
- •Abnormal laboratory findings or uncontrolled hypertension/diabetes meeting protocol-defined exclusion criteria.
- •Use of prohibited medications specified in the protocol.
- •Pregnant or breastfeeding women or women planning pregnancy.
- •Excessive alcohol consumption or smoking.
- •Participation in another clinical trial within the previous 3 months.
- •Subjects considered unsuitable by the investigator.
研究组 & 干预措施
Dietary Supplement : Subjects received FHH-MG tablets (900 mg; equivalent to 750 mg/day of FHH-MG) or matching placebo once daily (2 tablets/day) with sufficient water for 24 weeks.
干预措施: Dietary Supplement : Subjects received FHH-MG tablets (900 mg; equivalent to 750 mg/day of FHH-MG) or matching placebo once daily (2 tablets/day) with sufficient water for 24 weeks.