An efficacy evaluation of hair oil for hair fall reduction, growth and strengthening of hair in healthy Indian human volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in hair growth,reduction of hair fall and strength of hair in comparison to baseline as determined by Dermatological assessment
研究概览
简要总结
The study is double blinded Coconut oil controlled study to assess theinvestigational product (Herbs enriched oil -DRDC/2013/006) for the safety andefficacy in hair fall treatment, growth and strengthening of hair in healthyhuman Indian volunteers. The Studywill be conducted for a period of approximately 12 weeks for each subject andwill be evaluated at baseline, 4, 8 and 12 weeks. The subjects who satisfyinclusion, exclusion criteria will be enrolled after obtaining informedconsent. A total of 60 male and female subjects with complain of hair fall,damaged hair aged between 18-45 years (both the age inclusive) will be enrolledin the study.
Subjects will be asked to wash their hair on the day following oiling(twice a week only) day with Neutral Shampoo which will be dispensed along withthe test product.
Subjects will be assessed for Dermatologist’s assessment for safety andefficacy, Subject’s self assessment and Instrumentalassessment –Imaging, Strength of hair etc
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects in general good health.
- •â€¢Subjects in the age group 18-45 years (both the ages inclusive) •Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •â€¢Subjects complaining of hair loss, hair fall and damage •Subjects willing to abide by and comply with the study protocol.
- •â€¢Subjects who have not participated in a similar investigation in the past four weeks.
- •â€¢Subjects who have not used hair oil in past 2 weeks •Subjects who have not undergone any hair therapy in minimum 3 months •Healthy volunteers with no known allergy to any of the test ingredients •Subjects who show no sensitivity to test product.
- •â€¢Subjects who are willing to refrain from using dyes/henna/hair treatment throughout the study.
- •â€¢Subjects willing not to tie hair tightly.
排除标准
- •â€¢Subjects who are undergoing hair growth or hair straightening or transplant treatment 3 months before screening into the study •Subjects who have diseased Scalp conditions at the time of screening.
- •â€¢Subjects who have alopecia areata •Subjects who have treatments of chemotherapy within 6 months before starting study •Subjects who have history of addiction or drug abuse or psychiatric disorder •Subjects who use hairpiece during study terms •Subjects on oral medications or suffering from chronic illness which will compromise the study.
- •â€¢Subjects who are pregnant lactating or nursing •Subjects participating in other similar cosmetic or therapeutic trial.
- •â€¢Any underlying uncontrolled medical illness.
结局指标
主要结局
Improvement in hair growth,reduction of hair fall and strength of hair in comparison to baseline as determined by Dermatological assessment
时间窗: 12 weeks
次要结局
- •Safety of Investigational product by dermatologist and subjects.(•Improvement in overall condition of hair as assessed by dermatological and subject)