A Single Arm Pre And Post Clinical Study To Evaluate The Effect Of External Application Of Kusumbha Taila In The Management Of Hirsutism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Reduction in extent of hair growth using modified Ferriman-Gallwey Scoring.
研究概览
简要总结
PROPOSED TITLE –
“A SINGLE ARM PRE AND POST CLINICAL STUDY TO EVALUATE THE EFFECT OF EXTERNAL APPLICATION OF KUSUMBHA TAILA IN THE MANAGEMENT OF HIRSUTISMâ€
DURATION OF THE STUDY – 45 days per Subject
Hirsutism is defined as the presence of terminal hair with male pattern distribution in women. It is the main manifestation of hyperandrogenism in women, with a prevalence estimated at 65–75%, While in the general population, hirsutism affects around 4–11% of women and is the most common complaint presenting in the department for cosmetic reasons. Sex steroids and a number of local and systemic factors like humidity , temperature can act directly and indirectly on the dermal papilla to regulate hair growth. In response to the increased levels of androgens at puberty, vellus follicles in specific areas develop into terminal hairs. Androgens increase hair follicle size, hair fiber diameter, the proportion of time terminal hairs spend in the anagen phase and sebum secretion. Therefore, not only does androgen action alter the type of present hair, but also they will increase the oiliness of skin and hair. The Social stigma associated with hirsutism due to psychological stress, economic loss, isolation and inferiority complex will lead to a reduction in Quality of Life. Thus, there is a necessity for better and cost-effective management, which will reduce the severity of hirsutism.Even though various lomashatana yoga are mentioned in Kashyapa Samhitha, no toxicity studies have been conducted so far to prove the effect of herbo-mineral formulations in the management of hirsutism .It is found that Kusumbha Taila , mentioned in Bhaishajya Ratnavali , has lomashatana effect, and studies have been conducted to evaluate the safety use of Kusumbha taila.In literary search, no studies employing a validated tool for hirsutism have been conducted to substantiate the effect of classical formulations.
ESTIMATED COST –33,800 Rs approximately
Dr Ahana Salim
First Year P.G. Scholar
Dept. of Stri roga and Prasuti tantra
Amrita School of Ayurveda, Amritapuri,
Amrita Vishwa Vidyapeetham, India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects presented with complaints of facial hair with the score between 1 – 12 in modified Ferriman- Gallwey Score scale.
- •Patient without any menstrual irregularities Age group between 18-45 years Humidity related hyper androgenism and familial hyperandrogenism like conditons will be included.
排除标准
- •Pregnant and Lactating women Diagnosed cases of hypersensitive skin women choose not to abstain from using creams or oils.
- •Patient with any menstrual irregularities.
结局指标
主要结局
Reduction in extent of hair growth using modified Ferriman-Gallwey Scoring.
时间窗: 1st day and 45th day
Reduction in the density of hair using ImageJ software.
时间窗: 1st day and 45th day
Reduction in the hair count using Dermatoscope.
时间窗: 1st day and 45th day
次要结局
未报告次要终点
研究者
Dr Ahana Salim
Amrita School Of Ayurveda