A randomized controlled study comparing Herbal hair oil with coconut oil for the promotion of Hair growth in healthy adult volunteers.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Increase in hair length, reduction of hair loss and promotion of new hair growth
研究概览
简要总结
STUDY OBJECTIVES: To investigate the efficacy of Herbal hair oil in healthy adult volunteers by assessing the gross hair growth and counting the number of active hair follicles on the scalp.STUDY DESIGN: A randomized study over a 3-months period. Volunteers will be screened and eligible subjects during Visit 1 will be randomized to either Herbal hair oil b.i.d or Coconut oil b.i.d of similar appearance. Visits 2, 3, 4, 5 and 6 (final) will be scheduled at monthly intervals. Safety tests will be repeated at each of the study visits (except visit 2). Patients will enter adverse events and daily use of study medication in a subject diary. This will serve as a measure of compliance. Efficacy Assessment:
Overall efficacy assessment of hair oil is based on four point scale (i.e. bad, average, good & excellent) for hair & scalp related ailment. Patient will be undergoing monthly follow up for 3 months on the basis of following criteria:
a. Effectiveness – Hair growth/Hair fall control
b. Promotion of hair growth will be measured using trichoscopy c. Hair strength: tensile strength will be measured using Uni axial mechanical testing machine collecting hair of 5 cm long Analysis of scalp photograph: Trichoscopy data of all subjects from each group will be compared to check the efficacy of treatment along with tensile strength.
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 36.00 Year(s)（—）
- 性别
- All
入选标准
- •be informed of the nature of the study and will be asked to give a written consent 2.To have body weights within 25% of the appropriate weight range,
- •Must be free from significant diseases or clinically significant abnormal laboratory values during screening,
- •Normal ECG
- •Should not be taking any other treatment for hair growth
- •Must be able to communicate effectively with study personnel
- •hair fall due to chemotherapy.
排除标准
- •Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •History of allergic conditions – asthma, urticaria, eczema.
- •History of autoimmune disorders – lupus erythematosis (SLE)
- •History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
- •History of psychiatric disorders.
- •Recent history of alcoholism (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
- •Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period.
- •Androgenic alopecia
- •Presence of clinically significant abnormal laboratory results during screening.
- •Use of any recreational drugs or a history of drug addiction.
- •History of Anaemia
- •History of Dandruff, Head lice and pediculosis
- •History of irregular menstruation and PCOD
- •History of Hypo and Hyper Thyroidism.
- •History of Diabetes.
结局指标
主要结局
Increase in hair length, reduction of hair loss and promotion of new hair growth
时间窗: Increase in hair length, reduction of hair loss and promotion of new hair growth
次要结局
- Marketing of Evidence based Herbal hair oil for personal care(one year)