Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

Non Alcoholic Steatohepatitis Clinical Trial

Official title: A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

Status Withdrawn

Clinical Trial Summary

120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E.

Clinical Trial Description

The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups.

Baseline investigations:

Clinical characteristics

• Age

• Gender

• Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)

• Alcohol intake should be nil

Laboratory characteristics

• Hemogram, INR, KFT

• LFT (especially ALT, GGT) , APRI (AST to platelet ratio)

• Fasting Lipid Profile

• Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin )

• HOMA-IR (II)

• Serum uric acid levels Liver stiffness

• Fibroscan

• MR elastography Radiological characteristics

• USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers

• TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

• NCT number: NCT01384578
• Study type: Interventional
• Source: Institute of Liver and Biliary Sciences, India
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2011
• Completion date: November 2013