Chronic Kidney Disease
Conditions
Keywords
Curcumin, Pentoxiphylline, Chronic Kidney Disease
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
\- Curcumin capsules 500 mg twice daily for 6 months
\- Pentoxifylline 400 mg twice daily for 6 months.
Sponsors
Tanta University
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open labelled, three-arms, randomized, non-placebo, controlled, parallel clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in malonaldehyde biomarker | 6 Months | the change in biological marker (MDA) |
| The change in p-cresyl sulphate biomarker | 6 Months | the change in biological markers (pCS). |
| The change in high senstive c-reactive protiem biomarker | 6 Months | the change in biological marker (hs-CRP) |
| The change in proteinuria | 6 Months | the change in value of proteinuria |
| The change in estimated glomerular filtration rate | 6 Months | the change in eGFR |
| The change in serum creatinine and BUN | 6 Months | the change in values of serum creatinine and BUN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants losing the follow up | 6 Months | 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. |
Countries
Egypt
Outcome results
None listed