NCT01638234已完成2 期
Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Objective sleep measures as measured by actigraphs and SCORAD
研究概览
简要总结
Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months
排除标准
- •Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
- •Those who had received therapy for insomnia within 4 weeks before the baseline visit
- •Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
- •Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
- •Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
- •Pregnant and lactating women and those who are presently planning to get pregnant
- •Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study
结局指标
主要结局
Objective sleep measures as measured by actigraphs and SCORAD
时间窗: 4 weeks
actigraph parameters including sleep latency, sleep efficiency, total sleep time, and wake episodes and duration; SCORAD and objective SCORAD for disease severity assessment
次要结局
- urine and serum cytokines(4 weeks)
- total and allergen-specific IgE(4 weeks)
- sleep parameters measured by polysomnography(4 weeks)
- subjective improvement in symptoms(4 weeks)
研究者
研究点 (1)
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