A Clinical Study to Evaluate the Efficacy and Safety of Marham-e-Safeda Kafoori in the Management of Nar Farsi (Eczema)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema)
研究概览
简要总结
Nar Farsi (Eczema) is agroup of diseases that results in inflammation of the skin and characterized byitchiness, red skin, and a rash. There are various forms of NarFarsi(Eczema). Nar Farsi T’alluqi (Contact Eczema)is an inflammatory skin process caused by an exogenous agent or agents thatdirectly or indirectly injure the skin. Contact eczema results from a complexinteraction between external substances or contactant and skin. It accounts for4% to 7% of all patients presenting to the dermatology clinics. It isclassified as irritant or allergic. In irritant contact dermatitis (ICD), thisinjury is caused by an inherent characteristic of a compound –for example, aconcentrated acid or base. Agents that cause Allergic contact dermatitis (ACD)induce an antigen-specific immune response. The clinical lesion of contactEczema may be acute (wet and edematous) or chronic (dry, thickened,and scaly), depending on the persistence of the insult.
Irritant contact dermatitis (ICD) is defined asa non immunological inflammatory reaction of the skin to external agents whichcause direct toxic injury. It is caused by substances like alkalis, acids,organic solvents oxidants and reducing agent. Acute ICD is painful, associatedwith burning, stinging or itching. Mild irritants cause erythema, dryness andfissuring while strong irritants often cause oedema, blistering and ulceration.
Allergic contact dermatitis (ACD) occurs due toa delayed type 4 cell-mediated immunity. A minimum of 8 days to 10 days areneeded after sensitization for clinical allergy to manifest. Once sensitisationto an allergen occurs, it tends to persist throughout life. However, the degreeof sensitivity wanes with time unless repeated exposures occurs.
Allergic contact dermatitis may clinicallypresent acute after allergen exposure and initial sensitization or afterelicitation in a previously sensitized individual. Erythema, oedema, papules,vesicles and oozing are the cardinal signs of acute onset of eczematous ACD. InIndia the common sensitisers are plants specially parthenium hysterophorus,nickel, chromium and paraphenylene diamine. Parthenium allergy manifests as airborn contact dermatitis affecting the face, including the eyelids neck andflexures.
An enormous number of substances are capable ofcausing allergic contect dermatitis. Nickel dermatitis is one of the commonestexamples-some 5 percent of women in the UK are said to be nickel sensitive.Affected individuals cannot wear stainless-steel jewellery because of thenickel in the steel and develop a rash beneath steel studs, clips and buckles.Patients who are nickel sensitive may also react to dichromate and otherchromate salts.
The pathogenesis ofContact Eczema is complex and still incompletely understood. In management ofContact Eczema, topical steroids, immunosuppressant and bland emollients are inuse but they only suppress the symptoms and relapse is always there. Thespecific measures include emollients as well as steroids. The topical andsystemic steroid can cause several side effects.
Due to the high prevalence and non availability of safe and effectivetreatment, present study is being designed to Evaluate the Efficacy andSafety ofMarham-e-Safeda Kafoori in theManagement ofNar Farsi T’alluqi (Contact Eczema).
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of any sex in the age group of 18 to 65 years
- •Patients having the following symptoms:
- •Lichenification
- •Excoriation Hyperpigmentation Burnig Sensation Itching.
排除标准
- •Patients aged below 18 years and above 65 years
- •Patients on concomitant therapy
- •Co-morbid patient
- •Patients suffering from: Diabetes mellitus, Hypertension
- •Pregnant and Lactating women.
结局指标
主要结局
To evaluate the efficacy of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema)
时间窗: at baseline, 7th, 14th, 21st, 28th, 35th and 42th day
To evaluate safety of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema)
时间窗: at baseline, 7th, 14th, 21st, 28th, 35th and 42th day
次要结局
- Assessment of safety of the study drug(at baseline, 7th, 14th, 21st, 28th, 35th and 42th day)
