A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of SafÅ«f Muá¹£affi KhÄá¹£ plus topical Unani Formulation in the Management of NÄr FÄrsÄ« (Eczema)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in EASI Score from baseline
研究概览
简要总结
Eczema is a particular pattern of inflammatory response in the skin, of which spongiosis (epidermal edema) is the hallmark it may be included by both internal factors acting singly or in combination. According to unani system of medicine, it is an Afunati (infectious) skin disorder with eruptions having severe burning sensation and itching.It is caused by safra (yellow bile) mixed with small quantity of sawda (black bile) or haadd safrii (Acrid yellow bile) mixed with Dam(Sanuine) and usually occurs during epidemics.Keeping all this facts in consideration the present study has been planned to evaluate the safety and efficacy of Safuf -e -Musafi-e-khas for oral and a topical unani formulation Marham (Ointment) compared to levocitrizine orally and clobetasol propionate 0.05% topically in the management of Naar Faarsi (Eczema)
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.Participants of any gender between 18 to 65 years 2.Participants having the following any signs and symptoms of disease likeItching, Erythema, Visible flexural eczema, Excoriation, Hyperpigmentation, Burning sensation,Lichenification, Crusting, Dry skin 3.Chronicity of more than 6 months and less than 2 years.
排除标准
- •1.Known cases of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
- •2.Any other clinical condition that in the opinion of the investigator wouldcompromise the patient’s safety or successful participation in the trial.
- •3.Pregnancy and Lactation
- •Known allergy, sensitivity or intolerance to the study drug or any of its ingredients 5.
结局指标
主要结局
Reduction in EASI Score from baseline
时间窗: 56 DAYS
次要结局
- Improvement in CDSQ Score from baseline(56 DAYS)
研究者
Asra Sultana
National Research Institute of Unani Medicine for Skin Disorders