Non Alcoholic Steatohepatitis
Conditions
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.
Interventions
DRUGVitamin E plus Pentoxiphyllin
Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
DRUGVitamin E
Vitamin E 400 mg BD daily for 12 months
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score]) | Baseline and 1 year |
Secondary
| Measure | 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 |
Countries
India
Outcome results
None listed