CTRI/2023/09/057704尚未招募2 期
A clinical study to evaluate the Anti-dandruff efficacy of ayurvedic products
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Significant reduction in dandruff flakes
研究概览
简要总结
The objective of the present clinical study is to investigate the efficacy of test products in controlling dandruff condition. Study volunteers will be selected basis inclusion and exclusion criteria. Post informed consent, volunteers will be enrolled into the study and undergo 2 weeks of wash off period. Subjects are provided with the test product and usage instructions will be provided. Volunteers will visit the venue and dermatological and instrumental assessments will be performed at week 1, week 2 and week 4. Test product treatment duration is 4 weeks, followed by 1 week of regression period.
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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteer presenting moderate to severe dandruff (at least shoulder length hair for females) as per dermatological assessment.
- •Volunteer in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •Volunteers agreeing to comply with following study restrictions: -Volunteers Willing to refrain from application of any other product/treatment on their scalp and hair shafts during the study period.
- •Not to apply any cosmetic, hair care product, test product and/or water 48 hours before scheduled visits.
- •Willing not to colour or dye their hair just before the study visits and during the study period.
排除标准
- •Volunteer pregnant or planning to become pregnant.
- •Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
- •Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
- •Volunteers with self-perceived sensitive skin.
- •Volunteers having chronic illness or had major surgery in the last year.
- •Volunteers undergoing any treatment of any skin condition on body.
- •Volunteers taking medication continuously/regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study.
- •Volunteers taking medication for any condition which the Investigator believes may influence the interpretation of the data.
- •Volunteers on food supplements.
结局指标
主要结局
Significant reduction in dandruff flakes
时间窗: Basline, Week 1, Week 2, Week 4. Week 5
次要结局
- Significant reduction in scalp itch(Basline, Week 1, Week 2, Week 4. Week 5)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Effect of the test product on dandruff controlCTRI/2023/09/057704Hindustan Unilever Limited
已完成
不适用
A study to test the effect of product in reducing dandruffCTRI/2021/12/038437Unilever Industries Pvt Ltd160
已完成
不适用
Hair Benefit Study For The Test RegimeCTRI/2021/09/036884nilever Industries Pvt Ltd205
已完成
不适用
Hair Benefit Study For The Test ProductsCTRI/2021/09/036928nilever Industries Pvt Ltd207
已完成
不适用
Evaluation of anti-dandruff Efficacy of Test products On Healthy Human SubjectsCTRI/2017/05/008658ITC LIMITED ITC Life Sciences and Technology Centre47