A Clinical Study to Evaluate the Safety & Efficacy of Jeena Sikho Shuddhi Dr. Hair oil in Hair Growth and hairfall with Phototrichogram
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.SGA (Subject Global Assessment)
研究概览
简要总结
A single blind one group study multiple products study. The trial was conducted as per ICH E6 R2
Guidelines
Below Assessment will be done for 84 days on 36 Healthy Human Volunteers
A. Change in Hair growth, calculated as Subject’s assessment below:
-
Noticed first signs of hair growth
-
Noticed baby hairs or new hairs
-
Noticed darkening of scalp
-
Improvement in hair growth
-
Improvement in hair density
-
Noticed reduction in hair fall
B. Phototrichogram analysis
-
Change in Hair Density
-
Change in A-T Ratio
-
Change in Hair Thickness
-
Change in Percentage of Vellus Hair
-
Change in Percentage of Terminal Hair
Assessment Time: T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58 days, T+84 days and
T+86 days
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary man or women between 20 and 40 years.
- •Photo type III to V.
- •Having apparently healthy skin on test area
- •For whom the investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.Having refused to give her assent by not signing the consent form 3.Taking part in another study liable to interfere with this study 4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6.Having a progressive asthma (either under treatment or last fit in the last 2 years) 7.Being epileptic 8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) Having cutaneous hypersensitivity 9.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
- •Following a chronic or intermittent medicinal treatment comprising any of the following products : aspirin-based products, anti-inflammatories, anti-histamines, anti coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 11.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 12.Having changed her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit
- •Having applied a cosmetic product on the studied areas the first day of the study (except the usual shampoo).
结局指标
主要结局
1.SGA (Subject Global Assessment)
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 | days | T+58 days, T+84 days and T+86 days
Questionnaire
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 | days | T+58 days, T+84 days and T+86 days
2.HD Imaging
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 | days | T+58 days, T+84 days and T+86 days
3.Phototrichoscan Assessment
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 | days | T+58 days, T+84 days and T+86 days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories