Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Non Alcoholic Steatohepatitis

Treatments: Drug: Vitamin E plus Pentoxiphyllin; Drug: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT01279434

ILBS/DHPT/CT/006

Details and patient eligibility

About

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve NASH when used alone, a combination of these two should be expected to give better results because of targeting two different pathogenetic mechanisms (cytokines amplification and oxidative stress) in NASH patients. This will be open labelled, prospective, randomized study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings suggestive of fatty liver and presence of insulin resistance or features of metabolic syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all cases.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of NAFLD by ultrasonographic
• Presence of Insulin resistance
• Histological confirmation of NASH
• Increased transaminases (>1.5 upper limit normal [ULN])

Exclusion criteria

• Patients with alcohol > 20g/ day
• Other known liver disease
• Medications known to induce fatty liver

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Vitamin E plus Pentoxiphyllin

Experimental group

Treatment:

Drug: Vitamin E plus Pentoxiphyllin

Vitamin E

Active Comparator group

Treatment:

Drug: Vitamin E