A Randomized comparative clinical end point study to assess the Efficacy and safety of Herbodaya Bringa Hair oil and Shikaka Hair Wash in hair regrowth in male and female subjects with hair loss disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Change in global photographic assessment for hair growth.
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria willbe enrolled in the study
The selected subjects should be randomized for test and controltherapy.
The Test arm 1 will receiveHerbodaya Bringa Hair oil & Shikaka Hair Wash. The subjects will be asked to take 5-10ml of the hair oiland gently apply & massage the oil daily for a period of 12 weeks. Theywill be asked to apply the oil from the ends towards the roots of the hairfollicles, hair root, scalp and to the length of the hair. The oil will beallowed to work on the scalp overnight. Herbodaya Shikaka hair wash will beused to wash the hair twice a week for 12 weeks.
The Reference arm 2 will receive Indulekha bringha hair oil. Thesubjects will be asked to take 5-10ml and gently apply & massage the oildaily for a period of 12 weeks.
The Reference arm 3 will receive Dhatri hairoil. The subjects will be asked to take 5-10ml and gently apply & massagethe oil daily for a period of 12 weeks.
The primary and secondary outcome will be analyzed on 4th, 8th and 12th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with hair loss disorders such as telogen effluvium (as first line therapy), chronic female pattern hair loss, Androgenetic Alopecia (Stage I – IV)
- •Subjects who are willing to give written informed consent.
排除标准
- •1.Androgenetic alopecia (Stage V and beyond) 2.Evidence of dermatological disease as revealed by history, physical examination or laboratory assessment which may interfere with administration or assessment of study medication 3.Current use of dermatological drugs / preparations which may interfere with study evaluation.
- •4.Intolerance to any of ingredients of the formulation 5.Current alcohol or drug abuse 6.Subjects viewed by the investigator as not being able to complete the study.
- •7.Use of Hair product such as hair dyes, sprays, setting gels and restorers 8.Any procedures for hair enhancement and curling or straightening technique 9.Pregnant or breastfeeding women
- •Having abnormal thyroid profile.
结局指标
主要结局
1. Change in global photographic assessment for hair growth.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
2. VAS- Visual analog scale.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
3. Change in the investigator assessment score for Hair count in each
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
visit from enrollment onwards after treating with IP.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
4. Subjective Assessment by the subjects using diary card
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
Evaluation technique.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
5. Percentage of subjects responding to the therapy.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
6. Acceptability of the treatment.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
7. Global assessment for efficacy by Investigator and subjects.
时间窗: AT 4 weeks, 8 weeks and 12 weeks.
次要结局
- Frequency of adverse events measured(4,8 and 12 weeks)