Randomized comparative clinical study to evaluate the efficacy of grihadhoomadi ointment and dineshavalyadi taila in pama with special reference to superficial fungal dermatophytosis in children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant decrease in Superficial Fungal Dermatophytosis and Pama assessed based on Dermatophytosis Severity Score and Pama Lakshanas respectively.
研究概览
简要总结
Protecting and improving the health of children is of fundamental importance. One of the major illnesses in children are diseases related to the skin, skin being thin, tender, more delicate and easily susceptible to infections, it can range from mild and self- limiting conditions to more serious and chronic disorders affecting mind and other systems of the body. Living with a visible skin condition affects a child’s social and mental wellbeing, in turn affecting his/her growth in all dimensions. One of the common emerging skin disorders in children is Superficial Fungal Dermatophytosis. The prevalence of superficial fungal dermatophytosis has been increasingly growing at a rapid rate over the past few decades in industrialized and developing countries including India especially in younger children due to predisposing factors like warm, humid climate, crowded living conditions, hygiene and poor nutrition. This is probably due to the result of increase in number of immunocompromised children and sedentary lifestyle.
In Ayurveda skin diseases are explained under the heading of Kushta, Kshudra Rogas, Visarpa, etc. and Pamais a skin disease classified under Kshudra Kushta. Itis Kapha Pitta predominant and ischaracterized by Sweta, Aruna, Syava Pitikas, Srava, Kandu, Toda and Daha.
Hence, based on the signs & symptoms, Superficial Fungal Dermatophytosis is analogous to Pama which occur in mild, moderate and aggravated forms.
The treatment modality for superficial fungal dermatophytosis comprises of topical application of antifungal ointments, creams, and lotions; topical steroid applications, anti-histamines and moisturizers, which makes skin sensitive on regular usage and leads to flaring up of symptoms on discontinuation of treatment. Taking antifungal medicines for an extended period or failing to complete the prescribed treatment may lead to antifungal resistance making them even more difficult to treat.
Since Pama is Kapha-Pitta Pradhana Vyadhi, Chikitsa should be basically aimed at Sthanika Nirharana of Dushta Kapha and Pitta to alleviate Pidakas, Kandu etc. Very few formulations with such properties are mentioned in the classics for the treatment of Pama, some of them being evaluated for their efficacy, but the efficacy of Pamahara Yogas with special reference to superficial fungal dermatophytosis in children are never attempted so far. As such very few Ayurvedic antifungal creams are available in the market which are proven to be safe and effective with respect to childhood Dermatophytosis. The current study is the first of its kind to evaluate the efficacy and safety of Ayurvedic Pamahara Yogas mentioned in Balarogaadhikara for their antifungal activity in children.
The study aims at providing cost-effective remedy in management of Pama Kushta in children with negligible side-effects and low recurrence rate and hence, here arises the importance of unique formulations like Grihadhoomadi Ointment and Dineshavalyadi Taila where all the drugs are Kaphapittahara and Pamahara possessing Antibacterial, Anti-inflammatory, Anti-allergic and Antimicrobial Activities. Hence, this study is an attempt to evaluate the efficacy of GRIHADHOOMADI OINTMENT and DINESHAVALYADI TAILA in the management of Pama with special reference to Superficial Fungal Dermatophytosis in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Children in between the age group of 5 years to 10 years irrespective of religion, gender, and socio-economic status.
- •Children having the clinical features of Pama.
- •Children having the clinical features of Superficial Fungal Dermatophytosis.
- •Children whose parents are willing to sign the written consent form and follow the protocol.
排除标准
- •Chronic Superficial Fungal Dermatophytosis (more than 1 year duration).
- •Superficial Fungal Dermatophytosis associated with secondary infection and lichenification.
- •Children presenting with Invasive Fungal Dermatophytosis like Aspergillosis, Invasive Candidiasis, etc.
- •Other overlapping dermatological diseases like Atopic Dermatitis, Psoriasis, Scabies.
结局指标
主要结局
Significant decrease in Superficial Fungal Dermatophytosis and Pama assessed based on Dermatophytosis Severity Score and Pama Lakshanas respectively.
时间窗: 0th day - Before treatment | 14th day - after treatment | 21st day - follow up
次要结局
- Generation of in- depth analysed data on different aspects of the disease.(Generation of data on possible unexpected drug reaction.)
研究者
Dr Suryana Gupta
Sri Sri College of Ayurvedic Science and Research Hospital
