The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.
The main question it aims to answer is:
• Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?
Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.
详细描述
This study aims to investigate the effects of PSO supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients via assessment of IL-6, MDA, lipid profile, and kidney function tests.
Patients & Methods:
Design: Prospective, randomized, Open label - controlled clinical trial.
Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:
- Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
- Group 2 (Control group): consists of 28 patients who will not receive the intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients older than
- •Patients undergoing regular HD for at least 3 months prior to enrollment.
- •Not participate in any other clinical trials.
- •Physically stable.
排除标准
- •Patients taking antioxidant supplements prior to the study's two-month time frame.
- •Patients with autoimmune, liver, cancer diseases and acquired immunodeficiency syndrome (AIDS).
- •Sensitivity to pumpkin seed oil.
- •Patients taking warfarin.
- •History of drug or alcohol abuse.
- •Pregnant or breastfeeding women and women with the possibility of getting pregnant.
研究组 & 干预措施
Control group
Group 2 (Control group): consists of 28 patients who will not receive the intervention.
Pumpkin Seed Oil group
Group 1 (Pumpkin Seed Oil group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
干预措施: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. " (Dietary Supplement)
结局指标
主要结局
To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients.
时间窗: 12 weeks
To evaluate the effect of PSO supplementation on oxidative stress via measuring malondialdehyde (MDA) as oxidative stress marker.
To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients.
时间窗: 12 weeks
To evaluate the effect of PSO supplementation on the systemic inflammation via measuring interleukin-6 (IL-6) as inflammatory marker.
次要结局
- To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients.(12 weeks)
研究者
Merna Nasry
Demonstrator of Clinical Pharmacy Department, Faculty of pharmacy, Ain Shams University
Ain Shams University