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

Study Overview
=================
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.

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

Conditions
-----------------
Non Alcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: Vitamin E plus Pentoxiphyllin
* Drug: Vitamin E


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E plus Pentoxiphyllin<br> | Drug: Vitamin E plus Pentoxiphyllin<br>* Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months<br>* Other names: Arm A;|
| Active Comparator: Vitamin E<br> | Drug: Vitamin E<br>* Vitamin E 400 mg BD daily for 12 months<br>* Other names: Arm B;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score]) |  | Baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of serum transaminases levels |  | Baseline and 1 year | 
| Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA). |  | Baseline and 1 year | 
| Improvement in HOMA-IR |  | Baseline and 1 year | 
| No worsening of fibrosis |  | Baseline and 1 year |