CTRI/2021/12/038437已完成不适用
Anti-dandruff efficacy of Ayurvedic product
Unilever Industries Pvt Ltd1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年12月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Significant reduction in total dandruff levels
研究概览
简要总结
Study will be conducted to assess the anti –dandruff efficacy of test product. After consenting and qualifying the inclusionand exclusion criteria subjects will be enrolled into the study. Post wash outperiod, test product will be dispensed to subjects as per randomization andpost base line assessment subjects will be instructed to use the product thricea week for 1 month period. Evaluation assessments will be done at different times points over a period of 6 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 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects in general good health.
- •2.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •3.Subjects with dandruff as per dermatologist’s assessment 4.Subjects willing to abide by and comply with the study protocol.
- •5.Subjects who have not participated in a similar investigation in the past three months.
- •6.Subjects who agree to refrain from using hair dye / hair colour during the study period.
- •7.Subjects willing to refrain from any type of hair treatment like perming, straightening etc.
- •during the study duration 8.Subjects willing to refrain from any other anti-dandruff treatment/ products.
排除标准
- •1.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •2.Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
- •3.Subjects (male) having androgenic alopecia, male pattern baldness’ not be included in study.
- •4.Subjects 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.
- •5.Subjects (females) who are pregnant or lactating 6.Subjects who have had hair transplant.
- •7.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •8.Chronic illness which may influence the cutaneous state.
- •9.Subjects participating in other similar cosmetic or therapeutic trial within last three months 10.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.
- •11.Subjects (males) who are having androgenic alopecia, male pattern baldness.
结局指标
主要结局
Significant reduction in total dandruff levels
时间窗: 4 weeks treatment and 2 weeks regression
次要结局
- Significant reduction in dandruff associated conditions(4 weeks treatment and 2 weeks regression)
研究者
研究点 (1)
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