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

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01279434
• Other study ID #: ILBS/DHPT/CT/006
• Status: Withdrawn
• Phase: N/A
• First received: December 25, 2010
• Last updated: May 27, 2015
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2011
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

Intervention

Drug:
• Vitamin E plus Pentoxiphyllin
Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
• Vitamin E
Vitamin E 400 mg BD daily for 12 months

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])		Baseline and 1 year	No
Secondary	Normalization of serum transaminases levels		Baseline and 1 year	Yes
Secondary	Reduction in serum levels of proinflammatory cytokines (TNF-a and IL-6) and Malondialdehyde (MDA).		Baseline and 1 year	No
Secondary	Improvement in HOMA-IR		Baseline and 1 year	No
Secondary	No worsening of fibrosis		Baseline and 1 year	No