Randomised controlled clinical trial to evaluate the efficacy of Ayurvedic Intervention in DADRU KUSHTHA with special reference to Dermatophytosis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be relief in kandu (itching) at the end of the treatment period.
研究概览
简要总结
TITLE
RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AYURVEDIC INTERVENTION IN DADRU KUSHTHA WITH SPECIAL REFERENCE TO DERMATOPHYTOSIS.
Background
All the skin diseases in Ayurveda have been classified under the broad heading of Kushtha. There are
eighteen types of kushtha roga which classified in to Mahakustha and ksudra kustha, Charaka explained Dadru under Kshudra Kushtha. Sushruta and Ashtanga Hridaya explained it under Mahakushta. Dadru is a tridoshaja vyadhi with predominant vitiation of Pitta and kapha dosha having clinical features like kandu(itching),Raga(erythema),Pidika (eruptions) and Utasanna mandala (elevated cicular skin lesion)according to charaka. As per Sushruta, it is Kapha Dosha involvement. It can be closely
related to Dermatophytosis in contemporary science.
Null Hypothesis [Ho]: There is no difference in the efficacy between ayurvedic intervention and standard contemporary intervention in Dadru kushtha with special reference to Dermatophytosis. Alternative Hypothesis [HA]: There is difference in the efficacy between ayurvedic intervention and contemporary standard intervention in Dadru kushtha with special reference to Dermatophytosis.
Number of Groups: There will be two groups: Ayurvedic Intervention group and Conventional standard group. Sample Size: Sample size required is 60 patients.
Duration of treatment: The duration of treatment will be 42 days. GROUPING Group A:- Intervention: Nishotha and Kutaki Churna , Paribhadra Rasa and Dadruvidravana Malhara Group B:- Intervention: Flucanazole and Ketoconazole 2%.
OUTCOME AND SIGNIFICANCE
The study aims to provide scientific evidence on Ayurvedic treatments as an alternative to conventional therapies, reducing dependency on ANTI FUNGAL and steroids while improving patients’ quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to participate in clinical trial and provide informed consent.
- •2.The patients fullfilling the diagnostic criteria of Dadru Kushtha lakshanas such as- A.
- •Kandu (itching) B.
- •Raga(erythma) C.
- •Pidika(eruptions) D.
- •Utasanna mandala(elevated circular lesions) 3.Patients with chronocity of illness less than five years.
排除标准
- •1.Patients with long-term history of steroid and cytotoxic treatment.
- •2.History of hypersensitivity or allergy to study drugs.
- •3.Patients having concomitant illness like uncontrolled Hypertension, Diabetes Mellitus and known case of HIV, Malignancy.
- •4.Patients having other associated skin disease like eczema, secondary bacterial infection, etc.
- •5.Patient participated in any clinical trial with in last six months.
- •7.Severe renal Impairment.
结局指标
主要结局
The primary outcome of the study will be relief in kandu (itching) at the end of the treatment period.
时间窗: Baseline to the end of the treatment period.
次要结局
- Secondary outcomes will include changes in subjective & objective parameters such as(kandu(itching), Raga(erythema), Pidika (eruptions) & Utasanna mandala (elevated circular skin lesion).)
研究者
Savnika
National Institute of Ayurveda