CTRI/2023/06/053922已完成2 期
A clinical study to evaluate the efficacy of the test products in improving hair growth & hair fall reduction.
Hindustan Unilever Ltd1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2023年6月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- 2. Significant reduction in Kesh chyuti or kalitya (hair fall)
研究概览
简要总结
Study will be conducted to assess the efficacy of test product in imparting Hair growth benefits. After obtaining Informed consent form and qualifying the inclusion and exclusion criteria, subjects will be enrolled into the study. The subjects will undergo 2 weeks of wash out. Post wash out period, test products will be dispensed to subjects. Post base line assessment subjects will be instructed to use the product thrice a week for 3 months. All evaluation assessments will be done at different times – 4 weeks, 8 weeks and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female volunteers in general good health with mild to moderate hair fall
- •Volunteers in the age group 18-50 years (both the ages inclusive).
- •Volunteers willing to give a written informed consent and agree to come for a regular follow up visit.
- •Volunteers willing to abide by and comply with the study protocol.
- •Volunteers who have not participated in a similar investigation in the past three months.
- •Volunteers with no known allergy as established by medical history.
- •Volunteers who do not smoke or drink alcohol.
- •Volunteers who are not crash dieting.
- •Volunteers who agree to refrain from using hair dye / hair colour during the study period.
- •Volunteers willing to refrain from any type of hair treatment like perming, straightening etc.
- •during the study duration.
- •Volunteers who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study.
排除标准
- •Volunteers who have undergone hair growth treatment within 3 months before screening into the study.
- •Volunteers having any active scalp disease which may interfere in the study dermatologist’s judgement.
- •Volunteers who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
- •Volunteers who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
- •Volunteers who have had hair transplants.
- •Volunteers who take pharmaceutical product which cause hirsutism (ex.
- •phenytoin) and finesteride for androgenic alopecia.
- •A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •Volunteers consuming alcohol and smoking
- •Volunteers on oral medications which will compromise the study.
- •Volunteers who are pregnant or lactating or nursing as established with medical history.
- •Volunteers under any medical treatment for hair problems
- •Undergoing any chemical hair salon treatment-straightening / perming / colour
- •Menopausal female volunteers as determined by medical history.
- •Pregnant and lactating female volunteers
- •Chronic illness which may influence the cutaneous state.
- •Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
结局指标
主要结局
2. Significant reduction in Kesh chyuti or kalitya (hair fall)
时间窗: 4, 8, 12 weeks
1. Significant improvement in hair growth, reduction in hair fall
时间窗: 4, 8, 12 weeks
次要结局
- Significant improvement in hair fibre thickness(4, 8, 12 weeks)
研究者
研究点 (1)
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