A RANDOMIZED CONTROLLED TRIAL ON THE EFFECT OF PATOLAKHADIRADI KASHAYA IN THE MANAGEMENT OF DADRU KUSHTA (DERMATOPHYTOSIS).
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
- Reduction in erythema itching and size of skin lesion
研究概览
简要总结
Dermatophytes are the most ubiquitous fungal pathogens worldwide responsible for majority of skin, hair and nail infections which belong to the group of organisms that are able to breakdown keratin in tissues. The predisposing factors being tropical climate, humidity, tight clothes, occlusive footwear, sharing personal items with an infected person, poor hygiene. It is presented as annular erythematous lesions with active border, central healing and itching. Dermatophytosis is ranked 6th among the dermatological conditions in Global Burden of Diseases in 2019. Superficial dermatophytosis affects 20-25% of world populations and is a common infective dermatosis in clinical practice. The current reported prevalence in India falls in a very wide range 6.09% - 61.5%. Study conducted by Verma SB et al, stated that there has been an increase in the incidence of dermatophytosis across the country in the past 5–6 years. And there has been a significant increase in the incidence of chronic, relapsing, recurrent cases of superficial dermatophytosis in India that are also often unresponsive to conventional drugs and doses of recommended antifungal treatment. Serious consequences are uncommon; however, the illness may be disfiguring and uncomfortable and spread of fungus is accelerated in hot and humid climate. Work done by Jamil RA et al, showed that quality of life was highly impaired in the patients with dermatophytosis and it also showed a significant association with financial burden. In Ayurvedic classics, the Lakshanas of Dadru are Kandu (itching), Raaga (erythema), Pidika (papules) and Udgata Mandala (raised circular patches), so Dadru can be established parallel to Dermatophytosis. Dadru is one type of Kushta where the vitiated Doshas Pitta and Kapha in turn vitiate Rasa, Rakta, Mamsa, Lasika and presents the Lakshanas over Twak. Treatment should aim at Vyadhivipareeta Chikitsa which helps in Samprapti Vighatana and helps in attaining Samyata of Dosha and *Dushya.*Patolakhadiradi kashaya has Patola, Khadira, Nimba, Indravaruni, Katurohini and Shunti which are predominantly Tikta, Katu, Kashaya Rasa, Laghu-Rooksha Guna, has Pitta – Kaphahara Karma. So, the formulation has been selected as the trial drug. Therefore, it is hypothesized that Patolakhadiradi Kashaya will be helpful in the breakdown of pathogenesis of this condition. Taking this all into consideration, this study entitled – “A Randomized controlled trial on the effect of Patolakhadiradi Kashaya in the management of Dadru Kushta (Dermatophytosis).†is undertaken.
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
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients between age group of 18-70 years Patients with reddish annular skin lesions with itching Patients with skin lesions over face trunk scalp groin region hands and legs.
排除标准
- •Patients below 18years and above 70 years Patients with lesions over mucosa membrane of the body Patients where they have skin lesions with exudation Patients with negative fungal culture Patients on corticosteroid therapy Pregnant and lactating women.
结局指标
主要结局
Reduction in erythema itching and size of skin lesion
时间窗: At basline | At 15th day | At 31st day
次要结局
- Improvement in Quality of life(15 days)
研究者
Dr Balajapalli Sri Saraswathi
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
