Evaluation of efficacy and safety of Polyherbal Unani formulations, ItrÄ«fal Shahtara orally and Marham Kharish Jadeed topically in the management of NÄr FÄrsÄ« (Eczema)
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.POEM (Patient Oriented Eczema Measure)
研究概览
简要总结
Eczema is an inflammatory skin condition clinically characterized by erythema, papules, scaling, vesicles, fissures, hyperkeratosis and symptoms such as itch and pain. Over the span of 2009 – 2019, the highest prevalence of Atopic dermatitis was noted among Swedish children with 34%. In India, point prevalence of Atopic dermatitis is 6.75% and that in older individuals was 11.4% .
Eczema can affect patient’s quality of life by causing emotional and physical distress, increased anxiety or social avoidance because of a continuous fear of being negatively judged, sleep deprivation, low self-esteem and even disability in more severe cases diminishing their occupational options.
In conventional system of medicine, the main treatment includes emollients and topical steroids whose prolonged use causes adverse effects like atrophy, striae, rosacea, telangiectasia, rebound dermatitis along with resistance, early ageing and various toxicities or allergies to preservatives in topical creams . Keeping in view the adverse effects and limitations of conventional system of medicine along with an impaired quality of life, there is an imperative need to explore better treatment options. Unani system of Medicine is an ancient, time tested medicine with a rich literature of dermatology in which renowned physicians have elaborately mentioned and successfully treated various skin disorders. In order to treat eczema, ta’adil-e-khilt (normalization of causative humour), mubarridat (coolants), murattibat (humectants) , Musaffi-i-Dam (blood purifiers) etc. were used by them. So, in order to transform the diversity of knowledge mentioned in the literature into valid evidences and for better documentation, this study has been conceived.
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 who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedure and capable of providing a signed informed consent form indicating the subject has been informed of all pertinent aspects of the study.
排除标准
- •1.Patients with an evidence of clinically significant and uncontrolled systemic illness.
- •2.Patients with a current diagnosis of active skin disease (e.g., psoriasis, lupus erythematosus) or skin infection (bacterial, fungal or viral) especially in place of eczema at the same time.
- •Patients who had been using topical steroids within past 14 days.
- •Pregnant and lactating women.
- •Patients who have a known history or clinically relevant allergy, in particular to any component of the study treatment.
- •Patients unlikely to cooperate with the study protocol.
结局指标
主要结局
1.POEM (Patient Oriented Eczema Measure)
时间窗: Baseline, 2nd week ,4th week and 6th week
2. EASI (Eczema Area and Severity Index) Score
时间窗: Baseline, 2nd week ,4th week and 6th week
3. Pruritus NRS Assessment
时间窗: Baseline, 2nd week ,4th week and 6th week
次要结局
- DLQI ( Dermatology Life Quality Index(Baseline & 6th week)
研究者
Madiha Akhtar
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
