Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients

NCT06458465 | Completed

• 1 other identifier: 0107820
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Curcumin; Pentoxiphylline; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Number of participants losing the follow up

  6 Months

Study Arms (3)

No Intervention: Patients receiving no intervention

NO INTERVENTION

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

Active Comparator: Patients receiving curcumin

ACTIVE COMPARATOR

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

Dietary Supplement: Curcumin

Active Comparator: Patients receiving pentoxiphylline

ACTIVE COMPARATOR

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

Drug: Pentoxifylline 400 MG

Interventions

Curcumin DIETARY_SUPPLEMENT

\- Curcumin capsules 500 mg twice daily for 6 months

Active Comparator: Patients receiving curcumin

Pentoxifylline 400 MG DRUG

\- Pentoxifylline 400 mg twice daily for 6 months.

Also known as: Trental

Active Comparator: Patients receiving pentoxiphylline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Tanta University: collaborator

Study Sites (1)

Nada Mustafa Kamel

Alexandria, Alexandria Governorate, 21648, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Curcumin; Pentoxifylline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open labelled, three-arms, randomized, non-placebo, controlled, parallel clinical trial.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 13, 2024
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 28, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)