Evaluation of varnya effect of varnya mahakashaya cream in periorbital melanosis: open label clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in signs of Periorbital Melanosis.
研究概览
简要总结
Periorbital Melanosis is a darkening of the skin caused by an increase in production of or distribution of melanin, it involves the lower eyelid sometimes extending to the upper eyelid. It is a cosmetic concern for a large number of individuals who relate it with significant impairment on quality of life. Despite of it being common, there are not much or very few studies published on Periorbital Melanosis. There are several treatment options available but there is a lack of evidence - based study. The use of topical depigmenting agents is the most widely reported method in the clinical management of POM. Periorbital Melanosis *i.e.*Akshikut Karshnya comes under the broad umbrella of features of aggravation of Vata and Pitta like Vaivarnya , blackish discoloration i.e.Karshnya, Dark coloration i.e.Shyavata which can also be categorized under disease predominant in Vata . Acharya Charaka has mentioned Varnyadashemani - a group of ten herbs for the enhancement of Varna. Chandana i.e. Santalum album, Tunga i.e. Mesua ferrea, Padmaka i.e. Prunus cyrasodius, Ushira i.e. Vetiveria zizaniodis, Madhuka**i.e. Glycyrrhiza glabra, Manjishtha i.e. Rubia cordifolia, Sariva i.e. Hemidesmus indicus, Payasya i.e. Ipomoia digitata, Sita *i.e.*Cynodon dactylon, Lata *i.e.*Cynodon dactylon. Varnya Mahakashaya is useful in internal *i.e.*Antaparimarjan chikitsa as well as external i.e. Bahiparimarjan chikitsa or treatment.
Detailed study of mode of action of all these dravyas will enlighten the different treatment modalities.
Extensive literature study of Varna and Varnya effect from Various Samhita is not done yet. Varnya Mahakashaya cream (VMC) in Periorbital Melanosis is not explored yet.Hence, it’s a need to transform the Varnya Mahakashaya ingredients into modified dosage form by developing Standard quality Varnya Mahakashaya cream. Varnya Mahakashaya decoction with its medicated Ghrit will be used for developing VMC, which will act on Bhrajak Pitta and Rakta dhatu to enhance skin complexion in POM. This research is an attempt to carry out a randomized, open label, single arm study to evaluate Varnya effect of Varnya Mahakashaya Cream in Periorbital Melanosis .
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects of Periorbital Melanosis diagnosed since last one year Age group between 18 to 40 years irrespective of their gender, religion and socioeconomic status.
排除标准
- •Subjects using another topical application or Internal Medication for Skin complexion enhancement Malignant melanoma.
结局指标
主要结局
Reduction in signs of Periorbital Melanosis.
时间窗: 30 days
次要结局
未报告次要终点
研究者
Dr Sarika Mahesh Bhujbal
Bharati Vidyapeeth Deemed to Be University College of Ayurveda
