Pentoxifylline Versus Pioglitazone In Non-Alcoholic Steatohepatiti (NASH) (NASH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Govind Ballabh Pant Hospital.
Recruitment status was  Recruiting
Information provided by:
Govind Ballabh Pant Hospital Identifier:
First received: May 19, 2008
Last updated: May 20, 2008
Last verified: May 2008
  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.

Condition Intervention
Metabolic Parameters and Liver Histology
Drug: Pioglitazone
Drug: Pentoxifylline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Of Metabolic Factors And Efficacy Of Pentoxifylline Versus Pioglitazone In Lean And Obese Nash (Non-Alcoholic Steatohepatitis) Patients.

Resource links provided by NLM:

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Improvement in metabolic profile and histology [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: Pioglitazone
Pentoxifylline 1200mg/day in 3 divided doses. Pioglitazone 30 mg/day in single dose
Other Names:
  • Pentoxifylline - Trental
  • Pioglitazone - Piosys, Pioglar
Drug: Pioglitazone
30 mg OD
Other Name: Pioglar
Active Comparator: B
Drug: Pentoxifylline
1200 mg/d
Other Name: Trental

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00681733

Contact: Barjesh Ch Sharma, MD, DM 91-011-2323-4242 ext 5203

Dr. Barjesh Chander Sharma Recruiting
New Delhi, India, 110001
Contact: Barjesh Ch Sharma, MD, DM    91-011-2323-4242 ext 5203   
Principal Investigator: Barjesh Ch Sharma, MD, DM         
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Principal Investigator: Barjesh Ch Sharma, MD, DM G B Pant Hospital Hospital, New Delhi
  More Information

Responsible Party: Dr. B C Sharma, professor, G B Pant Hospital, New Delhi, G B Pant Hospital, New Delhi Identifier: NCT00681733     History of Changes
Other Study ID Numbers: drakchaudhary 
Study First Received: May 19, 2008
Last Updated: May 20, 2008
Health Authority: India: Ministry of Health

Keywords provided by Govind Ballabh Pant Hospital:
NASH Pentoxifylline Pioglitazone

Additional relevant MeSH terms:
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents processed this record on April 27, 2016