NCT01279434

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Vitamin E plus Pentoxiphyllin	Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
DRUG	Vitamin E	Vitamin E 400 mg BD daily for 12 months

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2011-01-19
• Last updated: 2015-05-28

Locations

1 site across 1 country: India