Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients

Chronic Kidney Disease Clinical Trial

— CKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458465
• Other study ID #: 0107820
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2023
• Source: Alexandria University
• Contact: Nada Mustafa Kamel, BSc
• Phone: 01020481552
• Email: nada.m.kamel123[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Drug:
• Pentoxifylline 400 MG
- Pentoxifylline 400 mg twice daily for 6 months.

Locations

Country	Name	City	State
Egypt	Nada Mustafa Kamel	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

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