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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00681733
Recruitment Status : Unknown
Verified May 2008 by Govind Ballabh Pant Hospital.
Recruitment status was:  Recruiting
First Posted : May 21, 2008
Last Update Posted : May 21, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Metabolic Parameters and Liver Histology Drug: Pioglitazone Drug: Pentoxifylline

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : January 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008


Arms and Interventions

Arm Intervention/treatment
Experimental: A
Pioglitazone
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
Pentoxifylline
Drug: Pentoxifylline
1200 mg/d
Other Name: Trental


Outcome Measures

Primary Outcome Measures :
  1. Improvement in metabolic profile and histology [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681733


Contacts
Contact: Barjesh Ch Sharma, MD, DM 91-011-2323-4242 ext 5203 drbcsharma@hotmail.com

Locations
India
Dr. Barjesh Chander Sharma Recruiting
New Delhi, India, 110001
Contact: Barjesh Ch Sharma, MD, DM    91-011-2323-4242 ext 5203    drbcsharma@hotmail.com   
Principal Investigator: Barjesh Ch Sharma, MD, DM         
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT00681733     History of Changes
Other Study ID Numbers: drakchaudhary
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Govind Ballabh Pant Hospital:
NASH Pentoxifylline Pioglitazone

Additional relevant MeSH terms:
Pioglitazone
Pentoxifylline
Hypoglycemic Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Vasodilator Agents
Free Radical Scavengers
Antioxidants