A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient-oriented Scoring of Atopic Dermatitis (PO-SCORAD)
研究概览
简要总结
Atopic dermatitis (AD) is a chronic, relapsing condition, caused by gene interaction, and immunological, environmental and pharmacological abnormalities. Since last four decades, rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, research evidences are inadequate. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in treatment of AD. In this 6-months, double-blind, randomized, placebo-controlled trial (n=60), patients were randomized to receive either IHMs (n=30) or identical-looking placebos (n=30). Primary outcome measure was Patient Oriented Scoring of Atopic Dermatitis (PO-SCORAD); secondary outcomes were Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) – all were measured at baseline and every month, up to 6 months. Group differences were calculated on intention-to-treat sample. After 6 months of intervention, group differences became statistically significant favoring IHMs against placebos on the primary outcome. Group differences on the secondary outcomes, though favored homeopathy, still were non-significant. Thus, IHMs performed significantly better than placebos in treatment of AD in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Newly diagnosed cases of AD (ICD-10-CM code L20.9) as per UK diagnostic criteria
- •PO-SCORAD more than 10
- •Age: 18-65 years
- •Both sexes
- •Literate patients; ability to read Bengali
- •Patients giving written consent to participate
- •Patients already undergoing treatment for AD were planned to be recruited on completely stopping the medicines and after wash-out phase of 1 month.
排除标准
- •Patients who were too sick for consultation
- •Diagnosed cases of unstable psychiatric or uncontrolled or life-threatening systemic illness affecting QoL or any organ failure
- •Substance abuse and/or dependence
- •Pregnant and lactating women
- •Patients undergoing homeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
Patient-oriented Scoring of Atopic Dermatitis (PO-SCORAD)
时间窗: At baseline, and every month up to 6 months
次要结局
- Dermatological Life Quality Index (DLQI) questionnaire(At baseline, and every month up to 6 months)
- Atopic Dermatitis Burden Scale for Adults (ADBSA)(At baseline, and every month up to 6 months)
