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

Clinical Study Evaluating the Impact of Curcumin and Pentoxiphylline on Patients With Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Curcumin; Drug: Pentoxifylline 400 MG

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21648
    • Nada Mustafa Kamel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention: Patients receiving no intervention; Group one will not receive add-on therapy; they will receive standard care only.
Active Comparator: Active Comparator: Patients receiving curcumin; Group two will receive curcumin as an add-on therapy on daily basis	Dietary supplement: Curcumin; - Curcumin capsules 500 mg twice daily for 6 months
Active Comparator: Active Comparator: Patients receiving pentoxiphylline; Group three will receive pentoxiphylline as an add-on therapy on daily basis	Drug: Pentoxifylline 400 MG; - Pentoxifylline 400 mg twice daily for 6 months.; Other Names: Trental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in p-cresyl sulphate biomarker	the change in biological markers (pCS).	6 Months
The change in high senstive c-reactive protiem biomarker	the change in biological marker (hs-CRP)	6 Months
The change in malonaldehyde biomarker	the change in biological marker (MDA)	6 Months
The change in estimated glomerular filtration rate	the change in eGFR	6 Months
The change in serum creatinine and BUN	the change in values of serum creatinine and BUN	6 Months
The change in proteinuria	the change in value of proteinuria	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Curcumin; Pentoxiphylline
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Platelet Aggregation Inhibitors; Antioxidants; Protective Agents; Free Radical Scavengers; Vasodilator Agents; Phosphodiesterase Inhibitors; Radiation-Protective Agents; Curcumin; Pentoxifylline
• Other Study ID Numbers: 0107820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No