Clinical Study Evaluating the Impact of Curcumin and Pentoxiphylline on Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in p-cresyl sulphate biomarker
研究概览
简要总结
The aim of the study is to evaluate the impact of turmeric and pentoxiphylline on serum levels of protein-bound uremic toxin (p-cresyl sulfate), oxidative stress biomarker level (Malonaldehyde), inflammatory biomarker level (Highly sensitive C-reactive protein). In addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.
详细描述
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty chronic kidney disease patients will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH).
The 60 participants will be randomly assigned into 3 arms.
Group 1 (Control group; n=20): Patients will be treated with standard care only for 6 months. Group 2 (n=20): Patients will be treated with the same standard care plus curcumin capsules 500 mg twice daily for 6 months. Group 3 (n=20): Patients will be treated with the same standard care plus pentoxiphylline 400 mg twice daily for 6 months. 4. All patients will be submitted to :
Full patient history and clinical examination. Blood withdrawal in order to conduct lab work. 5. Patients demographic data will be recorded with respect to age, weight and other co-morbidities. 6. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 7. Results, conclusion, discussion and recommendations will be given.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old.
- •Both sexes.
- •Non-hemodialysis CKD patients (Stage III -V)
- •Patients matched in the duration of CKD.
- •Patients with albumin-to-creatinine ratio ≥ 30 mg/g.
- •Patients with serum Potassium < 5 mEq/L
排除标准
- •Patients with elevated level of potassium ≥ 5 mEq/L.
- •Patients with cancer.
- •Patients with kidney stones and urinary tract infection.
- •Patients with bleeding disorder.
- •History of drug allergy to study medications.
- •Pregnant and breastfeeding women.
研究组 & 干预措施
Active Comparator: Patients receiving curcumin
Group two will receive curcumin as an add-on therapy on daily basis
干预措施: Curcumin (Dietary Supplement)
Active Comparator: Patients receiving pentoxiphylline
Group three will receive pentoxiphylline as an add-on therapy on daily basis
干预措施: Pentoxifylline 400 MG (Drug)
结局指标
主要结局
The change in p-cresyl sulphate biomarker
时间窗: 6 Months
the change in biological markers (pCS).
The change in high senstive c-reactive protiem biomarker
时间窗: 6 Months
the change in biological marker (hs-CRP)
The change in estimated glomerular filtration rate
时间窗: 6 Months
the change in eGFR
The change in malonaldehyde biomarker
时间窗: 6 Months
the change in biological marker (MDA)
The change in serum creatinine and BUN
时间窗: 6 Months
the change in values of serum creatinine and BUN
The change in proteinuria
时间窗: 6 Months
the change in value of proteinuria
次要结局
- Number of participants losing the follow up(6 Months)