Pentoxifylline Versus Pioglitazone In Non-Alcoholic Steatohepatiti (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
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT00681733
First received: May 19, 2008
Last updated: May 20, 2008
Last verified: May 2008
  Purpose
  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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 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:
Pentoxifylline
Pioglitazone
Antioxidants
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

ClinicalTrials.gov processed this record on October 23, 2014