EFFECT OF INDIVIDUALISED HOMOEOPATHIC TREATMENT IN PATIENTS OF ATOPIC DERMATITIS ASSOCIATED WITH GENERALISED ANXIETY - AN OPEN LABEL PROSPECTIVE STUDY
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity Index (EASI) score for atopic dermatitis.
研究概览
简要总结
Atopic Dermatitis is a chronic relapsing skin condition which occupies a major portion of dermatological diseases. The disease emerges as a social problem by increasing indirect costs, such as visiting a doctor, absenteeism from work and school, and avoiding social interactions.The skin is the visible reflector of emotion and psychological disorder being just like a sensitive photographic plate on which emotional states such as anger by flushing, embarrassment by blushing and fear by paleness etc. are reflected. Hence this study is to show the efficacy of the individualised homoeopathic medicine on atopic dermatitis and to find out if there is any correlation between the skin symptoms of atopic dermatitis and generalised anxiety. The aim of the study is to evaluate the effect of individualised homoeopathic treatment in patients of atopic dermatitis associated with generalised anxiety. Patients who are suffering from atopic dermatitis and registered in the OPD and IPD of National Institute of Homoeopathy and fulfilling the inclusion and exclusion criteria will be taken as sample of this study. The period of the study is 12 months; each patient will be followed up for consecutive 6 months after inclusion in the study. Scoring for generalised anxiety using Generalised Anxiety Disorder (GAD-7) score will be done at the first visit(baseline) and at the end of 6 months.
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 of Atopic dermatitis fulfilling Hanifin and Rajka diagnostic criteria associated with generalised anxiety (having GAD-7 score of more than or equal to 10).
- •Patient age group 18-60 years, of any gender, of any religion, of any socio-economic background.
- •Patents must be knowing either Hindi or English or Bengali.
- •Patients willing to give written informed consent.
- •Patients already undergoing regular oral/topical conventional therapy for atopic dermatitis may be recruited only if the medications are stopped completely 3 months prior to the treatment.
排除标准
- •Patient who are already taking medication for Generalised Anxiety for long term or to be decided as per the present general health of the patient.
- •Patient suffering from any life threatening/ Psychiatric/ illness or Immuno-compromised state or other significant disease condition.
- •Patients with malignancy of any organ.
- •Pregnant or lactating women.
- •Substance abuse and/or dependence.
- •Patients not willing to give consent for participation in the study.
- •Patients not willing to undergo any investigations if advised.
- •Patients who continue to be under other method of treatment or therapy.
结局指标
主要结局
Eczema Area and Severity Index (EASI) score for atopic dermatitis.
时间窗: At baseline and 6th month
Generalised Anxiety Disorder (GAD-7) score for generalised anxiety
时间窗: At baseline and 6th month
次要结局
- To ascertain and shortlist the most frequently indicated Homoeopathic medicines in the treatment of patients of atopic dermatitis associated with generalised anxiety.(To ascertain the predominant miasm in treatment of patients of atopic dermatitis associated with generalised anxiety.)
研究者
Dr Neha Biswas
National Institute of Homoeopathy (Kolkata)