An efficacy evaluation of Dabur Ayurvedic Oil(DRDC/2014/014) for hair fall reduction, strengthening of hair and overall improvement in hair & scalp condition in healthy Indian human subjects.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- •To evaluate the efficacy of Dabur hair oil formulation in hair fall reduction strengthening of hair and overall improvement in hair & scalp condition in comparison to baseline.
研究概览
简要总结
The study is double blinded, monocentre and comparator control study to assess the investigational product for hair fall reduction, hair growth, strengthening of hair and overall improvement in hair & scalp condition in healthy Indian human subjects. The study will be conducted for a period of approximately 12 weeks for each subject and will include a total of 9 visits i.e.1st visit will be a screening visit during. The eligible subjects will be enrolled. Visit 2, 4, 6 and 8 will be followed by Visit 3, 5, 7 and 9 respectively.The subjects who satisfy inclusion, exclusion criteria and sensitivity test will be enrolled after obtaining informed consent. A total of 90 male and female subjects with complain of hair fall, damaged hair and have not used hair oil for 2 weeks and aged between 18-65 years (both the age inclusive) will be enrolled in 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 with the test product. Subjects will be assessed for Dermatologist’s assessment for safety and efficacy, Subject’s self assessment and Instrumental assessment –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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Male and Female subjects in general good health. •Subjects in the age group 18-65 years (both the ages inclusive). •Subjects willing to give a written informed consent and agree to come for a regular follow up visit. •Female Subjects falling under Grade
- •Grade 6 of hair loss severity grade evaluated as per standard photonumeric 6 point scale. •Male subjects falling under Grade 3– Grade 6 of hair loss severity grade evaluated as per Norwood scale. •Subjects willing to abide by and comply with the study protocol. •Subjects who have not participated in a similar investigation in the past two weeks. •Subjects complaining of hair fall and damage •Healthy volunteers with no known allergy to any of the test ingredients as established by medical history. •Subjects who show no sensitivity to test product. •Subjects who are not on crash dieting. •Subjects who agree not to change the brand of currently used hair colour, dye, treatment etc., if any during the study term. •Subjects willing to refrain from any type of hair treatment like head massage, oil application (on scalp), perming, etc. during the study duration.
排除标准
- •â€¢Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
- •â€¢Subjects having any active scalp disease which may interfere in the study.
- •â€¢Subjects who have treatments of cancer chemotherapy last 6 months before starting study or have a plan to do treatments of them during study terms.
- •â€¢Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
- •â€¢Subjects who have had hair transplant.
- •â€¢Subjects who take pharmaceutical product which cause hirsutism.
- •â€¢A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •â€¢Subjects on oral medications which will compromise the study.
- •â€¢Subjects who are pregnant lactating or nursing as established with medical history.
- •â€¢Chronic illness which may influence the cutaneous state.
- •â€¢Subjects participating in other similar cosmetic or therapeutic trial within last two weeks •Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
结局指标
主要结局
•To evaluate the efficacy of Dabur hair oil formulation in hair fall reduction strengthening of hair and overall improvement in hair & scalp condition in comparison to baseline.
时间窗: 12 weeks
•To evaluate the efficacy of Dabur Hair Oil formulation in hair fall reduction strengthening of hair and overall improvement in hair and scalp condition in comparison to marketed hair oil groups.
时间窗: 12 weeks
次要结局
- •Safety of Investigational product by assessment of site application reaction by dermatologist and subjects.(12 weeks)