Diet Restiction in Subjects With Behcet Disease and Complaint of Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- tinnitus handicap inventory
研究概览
简要总结
otogic problems are varied in bechet disorder, tinnnitus is one of these problems. obesity may increase this probelm
详细描述
Forty subjects with behcet disorder, excess weight, complaint o tinnnitus will divided to group I or group II. low caorie diet 12-week regeim wil be followed by 20-patient group I . the 20-patient group II will be waitlist.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •behcet disease
- •subjective tinnitus (bilateral)
排除标准
- •other autoimune diseases
- •refusal to participate
研究组 & 干预措施
group number 1
twenty subjects with behcet disorder, excess weight, complaint o tinnnitus will follow low caorie diet 12-week regeim
干预措施: diet restriction (Behavioral)
group number 2
twenty subjects with behcet disorder, excess weight, complaint o tinnnitus will will be waitlist without intervention
结局指标
主要结局
tinnitus handicap inventory
时间窗: it will be measured after 12 weeks
it will assess life quality
次要结局
- visual analog scale of severity of complint of tinnitus(It will be measured after 12 weeks)
- visual analog scale of discomfort induced by complint of tinnitus(It will be measured after 12 weeks)
- tinnitus reaction scale(It will be measured after 12 weeks)
- beck depression scale(It will be measured after 12 weeks)
- sate trait anxiety inventory(It will be measured after 12 weeks)
- body mass index(It will be measured after 12 weeks)
- satifiaction with life scale(It will be measured after 12 weeks)
- behcet diseae life quality scale(It will be measured after 12 weeks)
- insomnia severity index(It will be measured after 12 weeks)
- waist circumfereence(it will be measured after 12 weeks)
研究者
Ali Mohamed Ali ismail
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University