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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
Vitamin E 400 mg BD daily for 12 months
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])
Time frame: Baseline and 1 year
Normalization of serum transaminases levels
Time frame: Baseline and 1 year
Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA).
Time frame: Baseline and 1 year
Improvement in HOMA-IR
Time frame: Baseline and 1 year
No worsening of fibrosis
Time frame: Baseline and 1 year
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