Clinical trial NCT06458465: Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients
Official title: Clinical Study Evaluating the Impact of Curcumin and Pentoxiphylline on Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Curcumin
Pentoxiphylline
Chronic Kidney Disease
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open labelled, three-arms, randomized, non-placebo, controlled, parallel clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change in p-cresyl sulphate biomarker
timeFrame: 6 Months
measure: The change in high senstive c-reactive protiem biomarker
timeFrame: 6 Months
measure: The change in malonaldehyde biomarker
timeFrame: 6 Months
measure: The change in estimated glomerular filtration rate
timeFrame: 6 Months
measure: The change in serum creatinine and BUN
timeFrame: 6 Months
measure: The change in proteinuria
timeFrame: 6 Months
Secondary outcomes:
measure: Number of participants losing the follow up
timeFrame: 6 Months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Nada Mustafa Kamel
Study officials:
References: