NCT04660773Unknown2 期
NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 5 D-itching scale
研究概览
简要总结
Patients will be randomly assigned into 2 groups:
- Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
- Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-60 years.
- •End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
- •Refractory uremic pruritis.
排除标准
- •Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
- •Photosensitivity.
- •Contraindication or allergy to pregabalin.
- •Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.
研究组 & 干预措施
NB UVB phototherapy
Active Comparator
(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
干预措施: NB UVB phototherapy (Device)
pregabalin
Active Comparator
20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.
干预措施: Pregabalin (Drug)
结局指标
主要结局
5 D-itching scale
时间窗: two month
assessment of degree, duration, direction, disability and distribution of itching
次要结局
未报告次要终点
研究者
marwa eldeeb
lecturer of dermatology
Alexandria University
研究点 (1)
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