Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients (CKD)

Alexandria University

Status: Enrolling

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Curcumin; Drug: Pentoxifylline 400 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06458465

0107820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

No Intervention: Patients receiving no intervention

No Intervention group

Description:

Group one will not receive add-on therapy; they will receive standard care only.

Active Comparator: Patients receiving curcumin

Active Comparator group

Description:

Group two will receive curcumin as an add-on therapy on daily basis

Treatment:

Dietary Supplement: Curcumin

Active Comparator: Patients receiving pentoxiphylline

Active Comparator group

Description:

Group three will receive pentoxiphylline as an add-on therapy on daily basis

Treatment:

Drug: Pentoxifylline 400 MG