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Completed

NCT Number: NCT06458465

Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients

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.

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Key information

About this study

  • Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
  • All participants should agree to take part in this clinical study and will provide informed consent.
  • 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.

  • All patients will be submitted to :

Full patient history and clinical examination. Blood withdrawal in order to conduct lab work.

  • Patients demographic data will be recorded with respect to age, weight and other co-morbidities.
  • Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  • Results, conclusion, discussion and recommendations will be given.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curcumin

Dietary Supplement
  • Curcumin capsules 500 mg twice daily for 6 months

Pentoxifylline 400 MG

Drug
  • Pentoxifylline 400 mg twice daily for 6 months.

Other names: Trental

Primary outcomes

  1. The change in p-cresyl sulphate biomarker

    Time frame: 6 Months

    the change in biological markers (pCS).

  2. The change in high senstive c-reactive protiem biomarker

    Time frame: 6 Months

    the change in biological marker (hs-CRP)

  3. The change in malonaldehyde biomarker

    Time frame: 6 Months

    the change in biological marker (MDA)

  4. The change in estimated glomerular filtration rate

    Time frame: 6 Months

    the change in eGFR

  5. The change in serum creatinine and BUN

    Time frame: 6 Months

    the change in values of serum creatinine and BUN

  6. The change in proteinuria

    Time frame: 6 Months

    the change in value of proteinuria

Secondary outcomes

  1. Number of participants losing the follow up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Acronym: CKD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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