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For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. Among the examined nontraditional risk factors, an increase in oxidative stress as well as inflammation are postulated to contribute to excessive cardiovascular risk in this population.
Flavonoids are naturally occurring substances that possess various pharmacological actions and therapeutic applications. Some due to their phenolic structures have antioxidant effect and inhibit free radical-mediated processes, as well as anti-inflammatory effects. Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating, and antifibrotic action.
In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and compared to vit E, a well known antioxidant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | No Intervention | ||
| vit E | Active Comparator | 200mg 2 times per day for 3 weeks |
|
| Milk Thistle extract | Experimental | 1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks |
|
| vit E + Milk Thistle Extract | Experimental | 200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk Thistle extract | Drug | 1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| RBC Glutathion Peroxidase level | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma malondialdehyde | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghazal Vessal, PharmD, PhD | Shiraz University of Medical Sciences, Faculty of Pharmacy | Study Director |
| Bahram Shahriari, MD | Shiraz University of Medical Sciences | Principal Investigator |
| Jamshid Roozbeh, MD | Nephrology Urology Research Center, Shiraz University of Medical Sciences | Study Chair |
| masoumeh Akmali, PhD | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemazi Hospital | Shiraz | Fars | 71345 | Iran |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C000713827 | milk-thistle extract |
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| vit E | Drug | 200 mg twice daily for 3 weeks |
|
| vit E + Milk Thistle extract | Drug | 200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks |
|
| D052776 |
| Female Urogenital Diseases |
| 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 |