Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Hemodialysis; End Stage Renal Disease

Treatments: Drug: vit E; Drug: vit E + Milk Thistle extract; Drug: Milk Thistle extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01001845

53001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All hemodialysis patients age 18-60
• On hemodialysis for over 3 months, 3 times a week, and for 4 hours each time
• Signed informed consent

Exclusion criteria

• Heart Failure NYHA Class III or IV
• Recent MI (within 1 year)
• Use of anti-oxidant supplements: N-acetyl-cystein, Omega 3, Vit C, Vit E, green tea, soy extracts, pomegranate extract, grape extract..
• Hepatitis B or C
• Active Infection
• Psychiatric illness
• Active malignancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Lifestyle counseling

No Intervention group

vit E

Active Comparator group

Description:

200mg 2 times per day for 3 weeks

Treatment:

Drug: vit E

Milk Thistle extract

Experimental group

Description:

1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks

Treatment:

Drug: Milk Thistle extract

vit E + Milk Thistle Extract

Experimental group

Description:

200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks

Treatment:

Drug: vit E + Milk Thistle extract