NCT05627843招募中3 期
Effects of Curcumin on Inflammation and Oxidative Stress in Paediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- inflammatory marker
研究概览
简要总结
- The study will be a randomised, double blinded, placebo controlled design.
- It will include 2 groups : trial group and placebo group
- Patients in both groups are children on regular hemodialysis
- The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo capsule for 3 months
- All patients will be evaluated clinically, and laboratory at baseline, at 3 months after end of supplementation.
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, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female pediatric patients with weight of at least 30 kilograms.
- •Undergoing regular hemodialysis for at least 6 months.
排除标准
- •Bleeding disorders.
- •Chronic liver disease.
- •Diabetes mellitus.
- •Autoimmune diseases.
- •Receiving drugs that are contraindicated, or have major interactions with curcumin, and can't be discontinued or replaced.
- •Receiving corticosteroids, or immune-suppressants.
- •Patients taking any antioxidant supplements including vitamin E, ascorbic acid, omega -3 fatty acid, or L-carnitine within 3 months prior to enrollment in our study.
结局指标
主要结局
inflammatory marker
时间窗: 3 months
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
次要结局
- Oxidative stress markers(3 months)
研究者
Iman Mohamed Naguib Alagamy
Assistant lecturer at Misr university for science and technology
Ain Shams University
研究点 (1)
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