NCT05822661进行中（未招募）2 期
Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- serum Endothelin-1 (ET-1) level
研究概览
简要总结
The aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.
详细描述
Evaluation of the effect of black seed oil in hemodialysis patients via:
- Evaluation of serum Endothelin-1 levels
- Evaluation of serum Malondialdehyde (MDA) levels
- Evaluation of serum Total Antioxidant Capacity (TAC) levels
- Evaluation of Quality of Life (QOL)
- Evaluation of fatigue scale
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old
- •Three to four times per week hemodialysis
- •Being on hemodialysis for at least 6 months
- •Ability and willingness to cooperate in the study
排除标准
- •Pregnancy or lactation
- •Cigarette smoking or substance/alcohol abuse
- •Having active infectious diseases
- •Receiving steroidal or nonsteroidal anti-inflammatory drugs
- •Using Nigella sativa oil regularly
- •Changes in treatment methods (dialysis) or medications during the supplementation
结局指标
主要结局
serum Endothelin-1 (ET-1) level
时间窗: 8 weeks
marker of endothelial dysfunction
次要结局
- Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)(8 weeks)
- Quality of life questionnaire(4 weeks and 8 weeks)
- Fatigue severity(4 weeks and 8 weeks)
研究者
研究点 (1)
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