The Effect of Individualized Homoeopathic Medicines in Centesimal Potency in Comparison with Fifty-Millesimal Potency in the treatment of Atopic Dermatitis in Adults :An open -Label, Randomized Double -Arm Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Scoring Atopic Dermatitis (SCORAD)
研究概览
简要总结
Atopic dermatitis (AD) is the most common inflammatory skin disorder, affecting up to 25percent of children and 10percent of adults, depending on the geographical area, with almost 25percent of the patients reporting symptoms only after adulthood., The characteristic clinical features of the highly pruritic eczematous lesions, consisting of papules and patches and the subsequent exudation and excoriation in the acute phase as well as the chronic lichenified, hyperpigmented lesions. It ranks as the most prevalent skin disorder based on disability-adjusted life-years by the World Health Organization. A gradual increase in the prevalence of AD has been observed recently and it can be ascribed to environmental changes consequent to rapid development all over the world. A rising trend in AD has been observed in India also in last four decades. The predominant mode of treatment in modern medicine for AD not beneficent, steroid have marked side effects. long term corticosteroid use poses risk for adverse effects like skin atrophy. The effectiveness of homoeopathic drug in managing the AD needs to be verified .However , any adequately powered clinical trial to examine the efficacy of IH in treatment of AD has been lacking till date .This current work is aimed to compare the effectiveness of fifty millesimal potencies with that of centesimal potencies of individualized homoeopathic medicines(IHMs)in atopic dermatitis in adults.A 6 months, open-label, randomized, two parallel arms, clinical trial will be conducted on 70 patients of atopic dermatitis at the outpatients of The Calcutta Homoeopathic Medical College and Hospital. Participants will be randomized to receive IHMs, either in centesimal or in fifty millesimal potencies. Scoring for atopic dermatitis (SCORAD)will be the primary outcome measure; Dermatological life quality index(DLQI)will be the secondary outcome measures ;all will be measured at baseline and every month ,up to 6 months. Parametric and non-parametric tests will be used as inferential statistics as per normality or non-normality of data distribution respectively to detect group diffrences.Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 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.Newly diagnosed cases of AD(ICD-11 CODE EA80.2)nas per Hanifin Rajka diagnostic criteria, 2.SCORAD values more than 10, 3.Patients of18-65 years of age and of either sex, 4.Literate patients;ability to read Bengali and /or English 5.Patients giving written consent to participate in the trial, 6.Patients already undergoing treatment for AD were planned to be recuited on completely stopping the medicines and after wash-out phase of 1 month.
排除标准
- •1.Uncontrolled or life threatening illness,any organ failure and other comorbidities,vulnerable population-unconscious,ambulatory, 2.Patients who are too sick for consultation,differently abled,terminally ill or critically ill patients abuse and/or dependence 3.Pregnant and lactating women,puerperal mothers, psychiatric illness.
结局指标
主要结局
Scoring Atopic Dermatitis (SCORAD)
时间窗: At baseline,at every 4 weeks, upto 24weeks
次要结局
- Dermatological life quality index(DLQI)(At baseline,every 4 weeks,up to 24weeks)