Evaluation of The Effect of Rutin and Vitamin C on the Oxidative Stress in Hemodialysis Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The change in Erythrocyte sedimentation rate from the baseline will be assessed at the end of the study
研究概览
简要总结
The aim of the study is to evaluate the effect of rutin and vitamin C on selected oxidative stress and inflammatory markrers.
Patients will be recruited according to the inclusion and exclusion criteria and will be divided into 3 groups, Group 1: Patients will administer a combination of Vitamin C and Rutin (RUTA C 60 tablets) in a dose of 2 tablets 3 times daily for 4 months in addition to their standard therapy, Group 2: will administer vitamin C 500mg hard gelatin capsules (twice daily) in addition to their standard therapy for a period of 4 months, Group3 (Control group) will administer the standard therapy. Blood samples will be withdrawn for measurement of; MDA, TNF-α ,GSH-PX, C-RP levels and ESR.
详细描述
Evaluation of the Effect of Rutin and Vitamin C on the Oxidative Stress in Hemodialysis Patients
A Protocol Submitted for Partial Fulfillment of Master Degree in Pharmaceutical Sciences (Clinical pharmacy)
By:
Samia mohamed omar
Under supervision of
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of patients > 18 year old.
- •hemodialysis in the last 3 months or longer.
- •hemodialysis frequency 3 times per week or more.
排除标准
- •Treatment with antioxidant agents [such as vitamin C and E during the 2 preceding months prior to the study.
- •Active liver disease
- •pregnant patients or patients planning pregnancy.
研究组 & 干预措施
Ruta C 60 group
Ascorbic Acid/Rutoside 60 tablet , each tablet contains: Rutin 60mg and Ascorbic acid 160mg Dosage:2 tablets three times daily for 4 months
干预措施: RUTA C 60 (Drug)
C- Retard group
Ascorbic acid 500mg capsule dosage: 1 capsule two times daily for 4 months
干预措施: RUTA C 60 (Drug)
结局指标
主要结局
The change in Erythrocyte sedimentation rate from the baseline will be assessed at the end of the study
时间窗: At end of the study(After the end of the intervention immediately)
mm/hour
The change in Malondialdehyde(MDA) level from the baseline will be assessed at the end of the study (after the end of the intervention)
时间窗: At baseline(pre-intervention)
Micromole/L
The change of Tumor necrosis factor-alpha(TNF-alpha) level from the baseline will be assessed at the end of the study (after the end of the intervention immediately)
时间窗: At baseline(pre-intervention)
pg/ml
The change of Tumor necrosis factor-alpha(TNF-alpha) level from the baseline will be assessed at the end of the study
时间窗: At end of the study(After the end of the intervention immediately)
pg/ml
The change of C-Reactive protein(C-RP) level from the baseline will be assessed at the end of the study
时间窗: At end of the study(After the end of the intervention immediately)
mg/L
The change in Erythrocyte sedimentation rate from the baseline will be assessed at the end of the study Erythrocyte sedimentation rate (ESR)
时间窗: At baseline(pre-intervention)
mm/hour
The change of Glutathione peroxidase(GSH-PX) level from the baseline(pre-intervention) will be assessed at end of the study(After end of the intervention immediately)
时间窗: At end of the study (After the end of the intervention immediately)
Micromole/L
The change of Malondialdehyde(MDA) level from the baseline(Pre-intervention) will be assessed at the end of the study (after the end of the intervention)
时间窗: At end of the study (After the end of the intervention immediately)
Micromole/L
The change of Glutathione peroxidase(GSH-PX) level from the baseline will be assessed at end of the study(After end of the intervention)
时间窗: At baseline(pre-intervention)
Micromole/L
次要结局
- Quality of life of end stage renal disease patients on hemodialysis(At end of the study(After the end of the intervention immediately))
研究者
samia mohamed omar
Principal Investigator
Ain Shams University