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.
1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University. 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
\- Curcumin capsules 500 mg twice daily for 6 months
\- Pentoxifylline 400 mg twice daily for 6 months.
Nada Mustafa Kamel
Alexandria, Alexandria Governorate, Egypt
The change in p-cresyl sulphate biomarker
the change in biological markers (pCS).
Time frame: 6 Months
The change in high senstive c-reactive protiem biomarker
the change in biological marker (hs-CRP)
Time frame: 6 Months
The change in malonaldehyde biomarker
the change in biological marker (MDA)
Time frame: 6 Months
The change in estimated glomerular filtration rate
the change in eGFR
Time frame: 6 Months
The change in serum creatinine and BUN
the change in values of serum creatinine and BUN
Time frame: 6 Months
The change in proteinuria
the change in value of proteinuria
Time frame: 6 Months
Number of participants losing the follow up
Non-adherence to study medications, loss of follow-up, existence of intolerable side effects, shifting of patients to dialysis, changing of standard care medications and death.
Time frame: 6 Months
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