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Sponsored by: |
Govind Ballabh Pant Hospital |
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Information provided by: | Govind Ballabh Pant Hospital |
ClinicalTrials.gov Identifier: | NCT00681733 |
Condition | Intervention |
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Metabolic Parameters and Liver Histology |
Drug: Pioglitazone Drug: Pentoxifylline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study Of Metabolic Factors And Efficacy Of Pentoxifylline Versus Pioglitazone In Lean And Obese Nash (Non-Alcoholic Steatohepatitis) Patients. |
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 |
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A: Experimental
Pioglitazone
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Drug: Pioglitazone
Pentoxifylline 1200mg/day in 3 divided doses. Pioglitazone 30 mg/day in single dose
Drug: Pioglitazone
30 mg OD
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B: Active Comparator
Pentoxifylline
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Drug: Pentoxifylline
1200 mg/d
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barjesh Ch Sharma, MD, DM | 91-011-2323-4242 ext 5203 | drbcsharma@hotmail.com |
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 |
Principal Investigator: | Barjesh Ch Sharma, MD, DM | G B Pant Hospital Hospital, New Delhi |
Responsible Party: | G B Pant Hospital, New Delhi ( Dr. B C Sharma, professor, G B Pant Hospital, New Delhi ) |
Study ID Numbers: | drakchaudhary, drakchaudhary |
Study First Received: | May 19, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681733 History of Changes |
Health Authority: | India: Ministry of Health |
NASH Pentoxifylline Pioglitazone |
Obesity Liver Diseases Radiation-Protective Agents Vasodilator Agents Non-alcoholic Steatohepatitis (NASH) Antioxidants Pioglitazone |
Fatty Liver Cardiovascular Agents Pentoxifylline Hypoglycemic Agents Digestive System Diseases Phosphodiesterase Inhibitors Platelet Aggregation Inhibitors |
Vasodilator Agents Liver Diseases Radiation-Protective Agents Antioxidants Pioglitazone Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fatty Liver Enzyme Inhibitors |
Cardiovascular Agents Protective Agents Pentoxifylline Pharmacologic Actions Hypoglycemic Agents Digestive System Diseases Phosphodiesterase Inhibitors Therapeutic Uses Free Radical Scavengers Platelet Aggregation Inhibitors |