Chronic Kidney DiseaseCKDNCT06458465
Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients
A study testing Curcumin and Pentoxifylline 400 MG in people with Chronic Kidney Disease, run by Alexandria University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Curcumin and Pentoxifylline 400 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Curcumin, Pentoxifylline 400 MG
- Keywords
- Curcumin, Pentoxiphylline, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
- Curcumin capsules 500 mg twice daily for 6 months
Pentoxifylline 400 MGDrug
Also called Trental
- Pentoxifylline 400 mg twice daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Curcumin |
| Active Comparator: Patients receiving pentoxiphylline | Active comparator | Group three will receive pentoxiphylline as an add-on therapy on daily basis Receives: Drug: Pentoxifylline 400 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in p-cresyl sulphate biomarker
the change in biological markers (pCS).
Measured: 6 Months
The change in high senstive c-reactive protiem biomarker
the change in biological marker (hs-CRP)
Measured: 6 Months
The change in malonaldehyde biomarker
the change in biological marker (MDA)
Measured: 6 Months
The change in estimated glomerular filtration rate
the change in eGFR
Measured: 6 Months
The change in serum creatinine and BUN
the change in values of serum creatinine and BUN
Measured: 6 Months
The change in proteinuria
the change in value of proteinuria
Measured: 6 Months
Secondary outcomes (1)
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Oct 2023
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open labelled, three-arms, randomized, non-placebo, controlled, parallel clinical trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458465
- Sponsor's protocol ID
- 0107820
- Acronym
- CKD
- Status last verified
- Sep 2023
- First submitted
- 24 May 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Impact of Curcumin and Pentoxiphylline on Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06458465
- Acronym / sponsor ID
- CKD / 0107820
- Conditions
- Chronic Kidney Disease
- Keywords
- Curcumin, Pentoxiphylline, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open labelled, three-arms, randomized, non-placebo, controlled, parallel clinical trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: CurcuminGroup two will receive curcumin as an add-on therapy on daily basis |
| Active Comparator: Patients receiving pentoxiphylline | Active comparator | Drug: Pentoxifylline 400 MGGroup three will receive pentoxiphylline as an add-on therapy on daily basis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin- Curcumin capsules 500 mg twice daily for 6 months | Dietary supplement | Active Comparator: Patients receiving curcumin |
| Pentoxifylline 400 MGAlso: Trental- Pentoxifylline 400 mg twice daily for 6 months. | Drug | Active Comparator: Patients receiving pentoxiphylline |
Primary outcome
The change in p-cresyl sulphate biomarker
Time frame: 6 Months
the change in biological markers (pCS).
The change in high senstive c-reactive protiem biomarker
Time frame: 6 Months
the change in biological marker (hs-CRP)
The change in malonaldehyde biomarker
Time frame: 6 Months
the change in biological marker (MDA)
The change in estimated glomerular filtration rate
Time frame: 6 Months
the change in eGFR
The change in serum creatinine and BUN
Time frame: 6 Months
the change in values of serum creatinine and BUN
The change in proteinuria
Time frame: 6 Months
the change in value of proteinuria
1 secondary outcome
Number of participants losing the follow up
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin and Pentoxifylline 400 MG in people with Chronic Kidney Disease, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in p-cresyl sulphate biomarker (time frame: 6 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.