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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Non Alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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pentoxiphylline and Vitamin E

Group Type EXPERIMENTAL

pentoxiphylline and Vitamin E

Intervention Type DRUG

Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.

Vitamin E

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DRUG

Patients in control group will receive vitamin E 800 IU/day

Interventions

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pentoxiphylline and Vitamin E

Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.

Intervention Type DRUG

Vitamin E

Patients in control group will receive vitamin E 800 IU/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 70 years
* Persistently abnormal ALT \>1.2 times upper limit of normal
* Histological evidence of NASH/cirrhosis on liver biopsy. ( The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in Zone 3 of the hepatic acinus)

Exclusion Criteria

* A known case of Type 2 diabetes mellitus on treatment
* Alcohol intake of more than 40gm / week
* If they had evidence of cirrhosis with significant portal hypertension
* Ongoing total parenteral nutrition/ jejunal-ileal bypass
* Other known liver disease (Hepatitis A to E, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis)
* Medication like estrogens, amiodarone, MTx, tamoxifen, ATT
* Pregnancy or lactation
* Hypersensitivity to methylxanthines (e.g., caffeine, theophylline, theobromine )
* Recent retinal/cerebral hemorrhage
* Acute myocardial infarction or severe cardiac arrhythmias
* Impaired renal function
* Hypothyroidism

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No