Evaluation of HERBHAIR OIL to improve Hair Growth - A Pre-Post Assessment Clinical Trial
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hair Growth /Regrowth
研究概览
简要总结
Proposed Study is Single Centric Single Arm Clinical Trial with Pre-Post Assessment Design on HERBHAIR OIL external application on scalp once daily for 120 days in Healthy volunteers complaining of Hair loss, Low Density of Hair or Diffuse Hair. Study is post market study for generating more clinical data on already licensed Ayurveda Proprietary Preparation to promote hair growth. It does not guarantee miraculous effect on hair and based on classical Ayurvedic drugs for hair growth. Study will be on 50 heathy volunteers who will give consent to participate. Initial skin patch test will be done with external application hair prior to inclusion in study to prevent inclusion of subject allergic to the test product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female participants, whose age is more than 18 years;
- •Participants who are willing to give written, signed and dated informed consent to participate in the study.
- •Participants who are clinically diagnosed for diffuse hair, Hair loss, minimum hair growth.
排除标准
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •Known case of Hypersensitivity to Investigational drug content.
- •Patient using any other treatment for this indication at the same time
- •Received any other investigational medicinal therapy within 30 days and topical therapy within 7 days prior to screening
- •Patient suffering from any active general illness or have History of any general illness
- •Patient on chemotherapy/ Radiotherapy/Tuberculosis
- •K/C/O of Diabetes, Immuno compromised condition Like HIV I and II, HbsAg
- •Any condition or disease which is considered unfit for study and which may interfere with study therapy as decided by clinical investigator.
结局指标
主要结局
Hair Growth /Regrowth
时间窗: 0 day, 40th day, 80th day and 120th day
Increase in hair density (by Trichoscope)
时间窗: 0 day, 40th day, 80th day and 120th day
Improvement in Hair Texture
时间窗: 0 day, 40th day, 80th day and 120th day
Preventing Hair Loss
时间窗: 0 day, 40th day, 80th day and 120th day
•Dandruff, Itching, Dryness, Stiffness of Hair, Perspiration and Burning Sensation In Scalp
时间窗: 0 day, 40th day, 80th day and 120th day
次要结局
- Subjective: Hair Growth, Dandruff, Itching, Dryness, Stiffness of Hair, Perspiration and Burning Sensation In Scalp(Objective: Serum Ferritin levels)