A Clinical study to evaluate the efficacy of Khasa beeja tailam (Seed oil of Papaver somniferum) in Darunaka Vyadhi.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the absence or no visibility of dandruff flakes in comparison to the
研究概览
简要总结
‘Darunaka’ is mentioned as a dreadful disease of scalp, where-in skin of scalp iscracked, dried along with itching due to vitiation of Vata and Kapha doshas, under ‘KshudraRogas’ by Acharya Sushruta and Sharangadhara. Darunaka Vyadhi can be correlated withthe modern nomenclature of diseases as ‘Dandruff & Seborrheic Dermatitis of scalp accordingto the International Classification of Diseases (ICD 10 & 11).The major difference between‘Dandruff’ and Seborrheic Dermatitis (SD) is the area of skin being affected in both thediseases. Dandruff is limited to the scalp skin and wherein Seborrheic Dermatitis can spreadover the scalp and as well as other Seborrheic areas of the body. Dandruff involves flaking ofskin, itching without any visible inflammation. SD involves flaking or scaling of skin,itching, inflammation and prutitus.Dandruff is the most exploited scalp disease and ishaving very high incidence as much as 50% amongst urban population and it is rapidlyincreasing in rural population also. External usage of Ahiphena (Khakhasa) beeja (seeds ofPapaver somniferum Linn.) in Darunaka Vyadhi has been mentioned by AcharyaSarangadhara. Ahiphena (poppy) seed is an widely used spice and an edible ingredient inmaximum families across India for taste and normal poppy seeds are generally regarded assafe for internal consumption. Seedoil contains 70%-73% of linoliec acid, 13%-15% oleic acid, 10%-12.5% palmitic acid, 1%-2% stearic acid, 0.2%-0.7% linolenic acid and less percentage of tocopherols and havingdifferent pharmacological activities including topical applications. A pilot study is planned to evaluate the efficacy of the seed oil in dandruff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in General good health of either sex.
- •(Subjects without other specific health complaints.)
- •Subjects within the age group of 18-55 years.
- •Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
- •Subject exhibiting a slight to moderate dandruff or Seborrheic dermatitis of scalp on the total adherent and non adherent score after clinical examination, on Day
- •Subject having stopped any possible antidandruff treatment at least 2 weeks prior to Day 0.
排除标准
- •Associated with other dermatological conditions such as psoriasis etc.
- •Other Systemic illness.
- •Pregnant, lactating mothers, menopausal women.
- •Any Immuno-compromised patients and uncontrolled Diabetes
- •Systemic treatment with corticosteroids, antibiotics, immune-suppressants etc, or any modern treatment within 3 months before of this trial.
- •Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •Subjects, who have history of alcoholism, smoking, crash dieting and/or psychiatric disorder including trichotillomania.
- •Subjects who have had hair transplantation, who have taken pharmaceutical product which cause hirsutism(ex.phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems.
- •A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •Subjects on oral medications, undergoing any chemical hair salon treatmentstraightening / perming / colour / henna which will compromise the study.
结局指标
主要结局
To determine the absence or no visibility of dandruff flakes in comparison to the
时间窗: 0 day 1 week 2 weeks 4 weeks
baseline.
时间窗: 0 day 1 week 2 weeks 4 weeks
2.3.2. To determine the percentage reduction in dandruff level in comparison to
时间窗: 0 day 1 week 2 weeks 4 weeks
次要结局
- To evaluate the drug acceptance, safety & tolerance(0 day 1 week 2 weeks 4 weeks)