CTRI/2023/03/050218尚未招募2 期
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a topical Unani Formulation in the Management of NÄr FÄrsÄ« (Eczema)
National Research Institute of Unani Medicine For Skin Disorders1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月3日最近更新:
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
- 25% change in appearance and symptomatic relief will be considered significant
研究概览
简要总结
*NÄr FÄrsÄ« (*Eczema) is a chronic skin disease, with high incidence, and recurrence. Moreover, topical steroids used in the management of eczema impair barrier functions and exhibit the adverse effects, such as skin atrophy, pituitary adrenal axis suppression, and masked infections, and steroid withdrawal can lead to sudden and severe rebound aggression, thinning of skin with striae, bruising, delayed wound healing, depigmentation, etc. Thus, there is no promising cure for eczema; hence the present clinical study has been designed to evaluate the Safety and Efficacy of a topical Unani Formulation Habb-e- Akuta in the management of eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants having the following signs and symptoms of disease: Itching, History of Asthma / hay fever in 1st degree relatives, Visible flexural eczema, Excoriation, Burning sensation, Lichenification, Crusting, Dry skin.
- •Participants who are able and willing to comply with the protocol and to sign ICF
- •Chronicity of more than 6 months and less than 2 years.
排除标准
- •1.Participants aged Less than 18 years and more than 65 years
- •Known cases of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
- •Any other clinical condition that in the opinion of the investigator would compromise the patient’s safety or successful participation in the trial.
- •Pregnancy and Lactation
- •Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
- •Participants with active alcohol intake and/or drug abuse
- •Participants not willing to sign the ICF and to attend treatment schedule regularly.
结局指标
主要结局
25% change in appearance and symptomatic relief will be considered significant
时间窗: 42 days
次要结局
- Digital photography of all lesions will be done using conditions (fixed room, fixed lighting and fixed camera settings )(42 days)
研究者
研究点 (1)
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