Ignite Creation Date:
2025-12-18 @ 9:34 AM
Ignite Modification Date:
2025-12-23 @ 11:16 PM
Study NCT ID:
NCT01384578
Status:
None
Last Update Posted:
2015-10-12 00:00:00
First Post:
2011-06-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
Sponsor:
None
Organization:
Study Overview
Official Title:
A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
Status:
None
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups.
Baseline investigations:
Clinical characteristics
* Age
* Gender
* Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)
* Alcohol intake should be nil
Laboratory characteristics
* Hemogram, INR, KFT
* LFT (especially ALT, GGT) , APRI (AST to platelet ratio)
* Fasting Lipid Profile
* Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin )
* HOMA-IR (II)
* Serum uric acid levels Liver stiffness
* Fibroscan
* MR elastography Radiological characteristics
* USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers
* TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score
Baseline investigations:
Clinical characteristics
* Age
* Gender
* Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)
* Alcohol intake should be nil
Laboratory characteristics
* Hemogram, INR, KFT
* LFT (especially ALT, GGT) , APRI (AST to platelet ratio)
* Fasting Lipid Profile
* Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin )
* HOMA-IR (II)
* Serum uric acid levels Liver stiffness
* Fibroscan
* MR elastography Radiological characteristics
* USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers
* TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: