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| Name | Class |
|---|---|
| Tanta University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Active Comparator: Patients receiving pentoxiphylline | Active Comparator | Group three will receive pentoxiphylline as an add-on therapy on daily basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Dietary Supplement | - Curcumin capsules 500 mg twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nada Mustafa Kamel | Alexandria | Alexandria Governorate | 21648 | Egypt |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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Open labelled, three-arms, randomized, non-placebo, controlled, parallel clinical trial.
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| Pentoxifylline 400 MG | Drug | - Pentoxifylline 400 mg twice daily for 6 months. |
|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |