Effect of individualized homoeopathic medicine in cases of atopic eczema using fifty millesimal potency : an open - label observational study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1. Eczema Area and Severity Index (EASI)
研究概览
简要总结
Atopic eczema is a chronic, inflammatory, non-communicable skin condition characterized by intense itching, relapsing episodes, and a strong association with atopic diathesis. It commonly manifests in childhood but can persist into adulthood, significantly impacting quality of life. Homoeopathic treatment is frequently sought for eczema, yet research on its efficacy, particularly using fifty millesimal (LM) potency, remains limited. This study aims to evaluate the effect of individualized homoeopathic treatment using LM potency on atopic eczema. Conducted over 12 months, each of the 64 participants will be followed for 6 months post-inclusion. The study will assess changes in the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), and quality of life using the Dermatology Life Quality Index (DLQI). Participants will be recruited from the inpatient and outpatient departments at the National Institute of Homoeopathy. Screening involves a detailed clinical assessment, including history-taking and evaluation of atopic conditions. Data collection will include both qualitative and quantitative measures, analyzed using statistical methods. The study adheres to Institutional Ethical Committee (IEC) guidelines, with findings intended for academic dissemination and potential publication. The score obtained by the patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients with atopic eczema who fulfill the Hanifin and Rajka diagnostic criteria.
- •Patients between the ages of 18 and 60 years.
- •Patients of both genders, all religious backgrounds, and any socioeconomic status.
- •Patients who are literate, who can read/ understand either english, hindi, bengali.
- •Patients who are willing to participate in the study and provide written informed consent.
排除标准
- •Patients with other dermatological conditions, serious systemic illnesses, psychiatric disorders, or any other life-threatening illnesses.
- •Women who are pregnant or lactating.
- •Patients who are currently under substance abuse or dependence.
- •Patients who has been under Homoeopathic treatment within 3 months for any chronic illness.
结局指标
主要结局
1. Eczema Area and Severity Index (EASI)
时间窗: Baseline and 6th month
2. Validated Investigator Global Assessment for Atopic Dermatitis(vIGA-AD)
时间窗: Baseline and 6th month
次要结局
- Dermatology Life Quality Index (DLQI)(Baseline and 6th month)
研究者
Darsha K
National Institute of Homoeopathy
