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临床试验/NCT00494975
NCT00494975已完成不适用

The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Visual Analogue Scale (VAS) Score for Pruritus

研究概览

简要总结

The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating uremic pruritus and investigate the association between improvement of pruritus and change of serum parameters, including routine biochemical data, immune profile and dialysis adequacy.

详细描述

We would conduct a randomized study to evaluate the effect of NB UVB therapy on uremic pruritus. The intensity of pruritus will be evaluated using visual analog scale (VAS) score (0 [no pruritus]-10 most severe pruritus]) and a detailed questionnaire assessing various characteristics of pruritus at baseline . The patients with the intensity of pruritus VAS score more than 5 will be randomized to narrow band UVB and control group. Phototherapy was administered to the whole body surface 2-3 sessions per week for total 18 sessions in a UV irradiation cubicle. The dose increased from 210mJ/cm2 .Doses were increased by 10 % at every session. The control group received time-matched exposures to long-wave ultraviolet light. The investigator will determine the pruritic intensity at baseline every 3 sessions by VAS score and by detailed questionnaire at baseline and after 18 sessions. The blood sample will also be collected at baseline and after treatment to determine factors associated with improvement.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic kidney disease with moderate to severe uremic pruritus for longer than 2 months

排除标准

  • pregnancy history of photosensitivity photo-aggravated disease

结局指标

主要结局

Visual Analogue Scale (VAS) Score for Pruritus

时间窗: VAS score at baseline and after 6 -week phototherapy

a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus. 0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions

次要结局

  • Detailed Questionnaire at Baseline and After 18 Sessions(at baseline and after 18 sessions)

研究者

申办方类型
Other

研究点 (2)

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