A 6-Month Randomized Double-Blind Placebo-Controlled Trial Assessing the Efficacy of Oral and Topical Traditional Chinese Medicine Products on Alopecia and Canities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Hair Shedding Count
研究概览
简要总结
This will be a 6-month randomized, double-blind, placebo-controlled trial. A total of 152 participants with hair loss, including some with gray hair, will be enrolled and randomly assigned to four groups. Each group will receive a combination of oral capsules and hair tonic, to be used as directed for 24 weeks. Participants will attend three in-person visits, during which assessments-including hair-related tests and photographs-will be conducted to evaluate hair count and density. Additionally, 10 participants with gray hair from each group will undergo extra assessments focused on changes in hair color. All relevant clinical data will be systematically collected and recorded for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must sign the informed consent form prior to enrollment and fully understand the study's purpose, procedures, and potential adverse events.
- •Adults aged 18 to 60 years, both male and female; each group must include no less than 50% female participants.
- •Hair length must be greater than 5 cm.
- •Women must meet the Savin scale classification between grades 1-3 to II.
- •Men must meet the Norwood-Hamilton classification between stages II and VI.
- •At least 10 participants in each group must have gray hair, with a minimum of 5 gray hairs within a 1 cm × 4 cm area of the scalp.
- •Participants must not have undergone any special hair treatments-such as dyeing, perming, or styling-within the past two months.
排除标准
- •Pregnant or breastfeeding women, or individuals planning to conceive in the near future.
- •Individuals with medical conditions causing hair loss, such as refractory alopecia areata, inflammatory scarring alopecia, or psoriatic alopecia; or those diagnosed with other scalp or hair disorders.
- •Individuals with diagnosed psychiatric or psychological disorders, or those with long-term sleep disturbances or emotional regulation issues.
- •Use of anti-hair loss cosmetics or other hair growth-promoting products within the past 3 months.
- •Use of any systemic or topical medications known to affect hair growth within the past 6 months.
- •History of hair transplantation.
- •Curly hair.
- •Individuals with highly sensitive constitutions.
- •Individuals diagnosed with severe anemia or abnormal liver/kidney function during physical examination.
- •Participation in any other clinical trials involving the test area within the past 2 months.
- •Any other conditions deemed unsuitable for participation by the clinical investigators.
结局指标
主要结局
Hair Shedding Count
时间窗: Baseline, week 12, week 24
Combing the hair 60 times and recording the number of hairs that fall out during the process
Local Hair Count
时间窗: Baseline, week 12, week 24
Detected by Dermatoscope
Local Hair Density
时间窗: Baseline, week 12, week 24
Detected by Dermatoscope
percentage of Vellus Hair
时间窗: Baseline, week 12, week 24
Detected by Dermatoscope
Percentage of Terminal Hair
时间窗: Baseline, week 12, week 24
Detected by Dermatoscope
Scoring of Hair Changes from Images
时间窗: Baseline, week 12, week 24
Doctor scores hair changes from Images pictured by camera with scale of 0 to 4
次要结局
- local hair color scores and white hair Index(Baseline, week 12, week 24)
- Complete Blood Count concentrations(Baseline, week 24)
- Urinalysis concentrations(Baseline, week 24)
- Aspartate Aminotransferase concentrations(Baseline, week 24)
- Alanine Aminotransferase concentrations(Baseline, week 24)
- Creatinine concentrations(Baseline, week 24)
- Urea Nitrogen concentrations(Baseline, week 24)
- Serum Uric Acid concentrations(Baseline, week 24)
- Adverse Events(Baseline, week 24)