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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin E plus Pentoxiphyllin

Group Type EXPERIMENTAL

Vitamin E plus Pentoxiphyllin

Intervention Type DRUG

Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months

Vitamin E

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DRUG

Vitamin E 400 mg BD daily for 12 months

Interventions

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Vitamin E plus Pentoxiphyllin

Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months

Intervention Type DRUG

Vitamin E

Vitamin E 400 mg BD daily for 12 months

Intervention Type DRUG

Other Intervention Names

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Arm A Arm B

Eligibility Criteria

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Inclusion Criteria

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