Evaluation of the safety and efficacy of Sharbat Unnab and Topical Unani formulation (Tila) in the management of Nar farsi(Eczema): An open label randomized controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1. Patient Oriented Eczema Measure (POEM)
研究概览
简要总结
Eczema, also known by the names of Nar farsi, Chajjan or Akota in the Unani system of medicine. The word Nar farsi which means Intense itching and burning was originally used in Persia, or the individual who used it was from Persia. The Greek term ekzein which means to boil forth and effervescence is where the word eczema first appeared in writing in AD 543. It can affect anybody, regardless of age or gender and is clinically characterized by varying degrees of clinical manifestations including dryness, erythema, excoriation, exudation, fissuring, hyperkeratosis, lichenification, papulation, scaling and vesiculation. In pediatric and adult studies, the prevalence of atopic dermatitis ranged from 0.98% to 9.2%. Eczema is a disabling condition that causes its sufferers to have socioeconomic issues including insomnia, anxiety, personality disorders, and difficulty carrying out everyday tasks. Patient’s quality of life is diminished by this illness. Conventional treatment includes topical corticosteroids to manage eczema and moisturizers or emollients to relieve dry skin. Several adverse effects, including skin atrophy, hair loss, weight gain, nephrotoxicity, hepatotoxicity, etc. have been linked to the use of systemic corticosteroids. This leads us to look for alternative safe and effective option to treat Nar farsi. Unani system of Medicine is very ancient and rich system of medicine. Though the ancient Unani physicians successfully treated Nar farsi and mentioned their experiences in Unani classical literature but their proper documentations on the recent scientific parameters is yet to be done, in order to convert these experiences into evidences to benefit the masses with confidence. Keeping in view of the fact this study is designed to clinically evaluate the safety and efficacy of an Unani ancient formulation on scientific parameters.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients willing to get enrolled in the study with informed consent & follow the protocol.
- •Diagnosed cases of eczema as per Hannifin and Rajka criteria.
- •Patients willing to attend treatment schedules regularly.
排除标准
- •Pregnant or lactating women.
- •Diabetic patients.
- •History of unstable pulmonary /cardiovascular / hepato-renal dysfunction or any other serious comorbid condition & known cases of immunocompromised states like AIDS etc.
- •4.Patients not willing to attend treatment schedule regularly.
结局指标
主要结局
1. Patient Oriented Eczema Measure (POEM)
时间窗: At baseline , 14th , 28th and 42nd day
次要结局
- 1. SCORing Atopic Dermatitis (SCORAD)(2.Eczema Area Severity Index (EASI))
研究者
Nadeem Iqbal
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
