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

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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384578

Enrollment

Registered

2011-06-29

Start date

2011-07-31

Completion date

2013-11-30

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Steatohepatitis

Brief 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.

Detailed 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

Interventions

DRUGpentoxiphylline and Vitamin E

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

DRUGVitamin E

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).	3 Months

Secondary

Measure	Time frame
Response in form of anthropometry , HOMA-IR, fasting lipid profiles, biochemical response in form of normalization of ALT and AST levels and reduction in uric	3 Months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026