Randomized placebo controlled single blind pilot clinical study to evaluate efficacy of herbal hair mist in hair re-pigmentation and the hair growth in healthy volunteers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in hair color from white to original color.
研究概览
简要总结
The purpose of this study is to check ability of prepared herbal formulation in change in hair color of ‘grey hair’ by photographic and questions based response of subject. Formulation application is topical. No any systemic investigation. Based on above assumption and considering the 20% dropout rate, we proposed to enroll 72 subjects as 36 in each group to get 60 cases (each group 30) at the end of study.
Further each group will be divided in two sub groups based on the age as 20-40 and 41-60 years.
Henceforth final groups for the study;
| Group |
Age
Treatment
No. of subjects
|I
20-40
Formulation
18
|II
41-60
Formulation
18
|III
20-40
Placebo
18
|IV
41-60
Placebo
18
Frequency of application: twice in a day
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Presence of gray hairs Person willing to sign an informed consent Person ready to stop application of any hair color or dye 15 days prior to treatment and throughout the treatment.
- •Person with normal hemoglobin count Either male or female.
排除标准
- •Person suffering from any life-threatening disease/disorder.
- •Person not willing to come for follow-up when required.
- •Person who is part of any other clinical trial.
- •Person having any allergy to included ingredients.
- •Other conditions which in opinion of the investigator make subject unsuitable for study.
- •Female with pregnancy.
结局指标
主要结局
Change in hair color from white to original color.
时间窗: 90 days
Safety assessment
时间窗: 90 days
次要结局
- Stimulation of hair growth(90 days)