Status:
UNKNOWN
Pentoxifylline Versus Pioglitazone In Non-Alcoholic Steatohepatiti (NASH)
Lead Sponsor:
Govind Ballabh Pant Hospital
Conditions:
Metabolic Parameters and Liver Histology
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
1. To assess the metabolic factors in lean and obese patients with NASH. 2. To compare the efficacy of pentoxifylline versus pioglitazone on the metabolic profile and liver histology of NASH patients.
Detailed Description
A total of 40 patients with biopsy proven NASH will be enrolled. Inclusion criteria * Abdominal USG showing diffusely echogenic liver suggestive of fatty infiltration of liver. * ALT \> 1.2 times th...
Eligibility Criteria
Inclusion
- Patients with biopsy proven NASH will be enrolled. Abdominal USG showing diffusely echogenic liver suggestive of fatty infiltration of liver.
- ALT \> 1.2 times the upper limit of normal for \> 6 months.(atleast three readings one month apart)
- Liver Biopsy showing steatosis affecting \>10% of hepatocytes with necroinflammatory activity, ballooning hepatocytes \&/ or fibrosis.
Exclusion
- Alcohol intake of more than 20g/wk
- Evidence of viral/ autoimmune hepatitis
- PBC (Primary biliary cirrhosis)
- Biliary obstrution
- Wilson disease
- Haemchromatosis
- Decompensated cirrhosis
- Drug ingestion of the follwing drugs for a period of more than 4 weeks during past 6 weeks - Amiodarone, Methotrexate, Perhexiline, Glucocorticoids, Estrogens, Tamoxifen, Nifedipine, Diltiazem, Tamoxifen.
- DM Type I
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00681733
Start Date
January 1 2007
End Date
December 1 2008
Last Update
May 21 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Barjesh Chander Sharma
New Delhi, New Delhi, India, 110001