ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES USING 50 MILLESIMAL POTENCY IN REDUCING ABSOLUTE EOSINOPHIL COUNT (AEC) IN PAEDIATRIC ATOPIC DERMATITIS: A SINGLE ARM PRE- POST ASSESMENT INTERVENTIONAL STUDY
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Atopic dermatitis (ICD10 L20.9) is a chronic, non-communicable, relapsing skin condition that predominantly affects infants and children, though it may present at any age. Its persistent nature often leads to considerable impairment in the quality of life of both patients and their families, with the recurring course exerting a negative influence on the developmental years of childhood. Homoeopathy is regarded as having wide applicability in the management of dermatological disorders, with potential benefits in controlling acute flare ups as well as addressing long standing cases. This study will involve paediatric patients diagnosed with atopic dermatitis, enrolled according to specified inclusion criteria. Each participant will receive individualized homoeopathic treatment in LM potency, prescribed on the basis of symptom similarity and tailored to the needs of the individual case. The primary outcome will be assessed through measurement of Absolute Eosinophil Count (AEC), while secondary outcomes will be evaluated using the SCORAD index and the Modified Naranjo Criteria for Homoeopathy (MONARCH). Patient enrolment will span twelve months, with each child being followed and evaluated for a period of six 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
- 3.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient in the age group of 3 to 17 years.
- •2.All gender, regions and races irrespective of socioeconomic status.
- •3.Patients fulfilling Hanifin and Rajka diagnostic criteria for atopic dermatitis.
- •4.Absolute eosinophil count (AEC) more than 500 cells per mm 5.Patients already undergoing oral/topical conventional therapy for Atopic dermatitis may be recruited after a washout period of 1 month.
- •6.Parent or guardian willing to give written consent; assent from children (Below 7 years: no assent required,7 to 11 years Verbal assent ,more than 12 years written assent) 7.Parent orguardian (or child, if more than 7 years) ability to understand Bengali or Hindi or English.
排除标准
- •1.Complicated cases of atopic dermatitis.
- •2.Patients with congenital anomalies, critically ill patients, immune compromised patient.
- •3.Patient suffering from any other uncontrolled systemic diseases.
- •4.Diagnosed cases of unstable mental or psychiatric illness.
- •5.Patient having any substance abuse.
研究者
Dr Amiya Dash
National Institute of Homoeopathy