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

Primary Purpose

Non Alcoholic Steatohepatitis

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vitamin E plus Pentoxiphyllin
Vitamin E
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin E plus Pentoxiphyllin

Vitamin E

Arm Description

Outcomes

Primary Outcome Measures

Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])

Secondary Outcome Measures

Normalization of serum transaminases levels
Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA).
Improvement in HOMA-IR
No worsening of fibrosis

Full Information

First Posted
December 25, 2010
Last Updated
May 27, 2015
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01279434
Brief Title
Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial
Official Title
Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin E plus Pentoxiphyllin
Arm Type
Experimental
Arm Title
Vitamin E
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin E plus Pentoxiphyllin
Other Intervention Name(s)
Arm A
Intervention Description
Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
Arm B
Intervention Description
Vitamin E 400 mg BD daily for 12 months
Primary Outcome Measure Information:
Title
Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])
Time Frame
Baseline and 1 year
Secondary Outcome Measure Information:
Title
Normalization of serum transaminases levels
Time Frame
Baseline and 1 year
Title
Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA).
Time Frame
Baseline and 1 year
Title
Improvement in HOMA-IR
Time Frame
Baseline and 1 year
Title
No worsening of fibrosis
Time Frame
Baseline and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ramesh Kumar, MD,DM
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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