Trials / Withdrawn
WithdrawnNCT01384578
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- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Institute of Liver and Biliary Sciences, India · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pentoxiphylline and Vitamin E | Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day. |
| DRUG | Vitamin E | Patients in control group will receive vitamin E 800 IU/day |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2011-06-29
- Last updated
- 2015-10-12
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT01384578. Inclusion in this directory is not an endorsement.