A Randomized open labelled controlled clinical study to evaulate the efficacy of Dadrughna Lepa in the management of Dadu Kushta with special reference to Fungal Dermatophytosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in KASI score
研究概览
简要总结
Skin is the largest organ of the human body. Its size and external location make it susceptible to a wide variety of disorders.In recent years, there has been a considerable increase in the incidence of skin conditions in the tropical and developing countries like india.Skin disorders are known to be the fourth most common causes of all human diseases affecting nearly 1/3rd of population in the world.All the skin diseases are explained under the heading of Kushta in Ayurveda. Dadru Kushta is one of the commonly occurring skin disease and is KaphaPitta predominant.ED-4.3.6 specific code that can be used to indicate the Dadru Kushta as mentioned in NAMASTE PORTAL (National Ayush Morbidity and standardised terminologies electrical portal).The symptoms like Durvavat deerghapradhana indicates its spreading nature, Athasi indicates its coppery red colour, Kandu(itching) and Anushangini its chronic nature.Most of the features of Dadru Kushta is similar to the features of dermatophytosis.Dermatophytosis is the fungal infection of the skin.It can be developed from 40 types of fungi, of which dermatophytes trichophyton,microsporum and epidermophyton are the common causative agents.B5.9 is a specific ICD-10-CM code to indicate the diagnosis of Dermatophytosis.The typical clinical presentation of this disease is red, itchy and scaly circular lesion.Globally,up to 20% of the human population may be infected by dermatophyte at a time. The last few years shows a significant rise in the incidence of chronic Dermatophyte infections of skin,which have been proven difficult to treat.In contemporrary medical science, management of Dermatophytosis is carried out with Topical fungicidal agents like natamycin, clotrimazole, econazoles, miconazoles etc and systemic anti-fungal agents like Griseofulvin, Ketocenazole are advocated. Systemic fungicidal are highly toxic.Topical fungicidal require prolonged application and recurrence poses a problem in addition to appearance of resistance and long lasting usage produce the adverse effect like flaking of skin, irritation, redness etc.Hence,there is a need to contribute with safe and cost effective remedy in management of Dadru Kushta to effectively manage the disesase and not to cause any ill effects on body.In Ayurveda,many effective formulations without side effects are available. A series of studies conducted in recent past comprising of topical applications have showed mild to moderate response in Dadru Kushta. Here arises the importance of unique formulation in the management of Dadru Kushta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •SUBJECTS FALLING UNDER B36 OF ICD10 CLASSIFICATION,CLINICAL SIGNS AND SYMPTOMS OF DADRU KUSHTA AS DESCRIBED IN CLASSICAL TEXTS (PRESENCE OF UDGATA MANDALA WITH OR WITHOUT OTHER SYMPTOMS),SUBJECTS WILLING TO PARTICIPATE IN THE STUDY WITH WRITTEN INFORMED CONSENT WHICH IS CONVEYED IN THE LANGUAGE WHICH THE SUBJECT CAN UNDERSTAND.
排除标准
- •PREGNANT AND LACTATING WOMEN.
- •SUBJECTS HAVING ANY UNCONTROLLED SYSTEMIC ILLNESS WHICH CAN INTERFERE WITH THE COURSE OF DISESASE AND TREATMENT, OTHER OVERLAPPING DERMATOLOGICAL DISEASES WILL BE EXCLUDED, SUBJECTS UNDER ANTI-FUNGAL DRUGS WILL BE EXCLUDED.
结局指标
主要结局
Changes in KASI score
时间窗: before intervention-0th day | during intervention-10th day | after intervention-21st day | follow up-28th day
次要结局
未报告次要终点
