Study of Oral Melatonin on Sleep quality and Blood pressure in Maintenance Hemodialysis patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Effect of oral melatonin on sleep quality, 24 hour ambulatory BP and depression scoring in maintenance hemodialysis patients
研究概览
简要总结
Patients with end stage kidney disease on hemodialysis commonly have sleep disturbances. Sleep disturbances have effect on blood pressure of the individuals. Benzodiazepines used to treat insomnia in maintenance hemodialysis patients have many adverse effects like drug dependence, light headedness and unsteadiness. Non benzodiapine drugs like melatonin can be used in the patients so as to avoid these side effects and also they have an effect on lowering blood pressure of the individuals. So,we are doing a single arm trial in maintenance hemodialysis patients more than 18 years with sleep disturbances with oral melatonin supplementation 5mg, so as to prove their beneficial effect on sleep disturbances and lowering BP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Maintenance hemodialysis patients who are more than 18 years
- •Dialysis vintage more than one year
- •Baseline Pittsburgh Sleep Quality Index more than 5.
排除标准
- •Less than 18 years, more than 65 years, with advanced liver disease, malignancy, heart failure, active infection, pregnancy, BMI more than 40, psychosis, patient on hypnotics.
结局指标
主要结局
Effect of oral melatonin on sleep quality, 24 hour ambulatory BP and depression scoring in maintenance hemodialysis patients
时间窗: 3 months after oral melatonin supplementation
次要结局
- Effect of oral melatonin on depression scoring(3 months supplementation)
研究者
Sakthirajan R
Madras Medical College