Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients

NCT ID: NCT06458465

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-10-01

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Intervention: Patients receiving no intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active Comparator: Patients receiving curcumin

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

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DIETARY_SUPPLEMENT

\- Curcumin capsules 500 mg twice daily for 6 months

Active Comparator: Patients receiving pentoxiphylline

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

Group Type: ACTIVE_COMPARATOR

Pentoxifylline 400 MG

Intervention Type: DRUG

\- Pentoxifylline 400 mg twice daily for 6 months.

Interventions

Curcumin

\- Curcumin capsules 500 mg twice daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Pentoxifylline 400 MG

\- Pentoxifylline 400 mg twice daily for 6 months.

Intervention Type: DRUG

Other Intervention Names

Trental

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nada Mustafa Kamel

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Other Identifiers

0107820

Identifier Type: -

Identifier Source: org_study_id