Role of VSL#3 in patients with nonalcoholic fatty liver disease
- Conditions
- Health Condition 1: null- Patients with Non alcoholic fatty liver disease
- Registration Number
- CTRI/2008/091/000074
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1.Patients with raised liver enzymes (AST/ALT) at least 1.5 times the normal for more than three months
2.No history of alcohol intake or intake less than 20g/d (to be confirmed from at least two family members)
3.Negative viral markers (HBsAg and anti HCV)
4.Negative autoimmune markers (anti nuclear anti bodies (ANA), anti smooth muscle antibody (ASMA), anti liver kidney microsomal antibody (anti LKM), antimitochondrial antibody (AMA)
5.Normal ceruloplasmin
6.Negative KF ring
7.Normal iron studies
8.Liver biopsy consistent with features of NAFLD
1.Pregnant females
2.Patients with diabetes mellitus
3.Patients with cirrhosis on imaging or liver biopsy
4.Patients with history of drug intake likely to cause NAFLD (e.g. corticosteroids, methotrexate, tamoxifen etc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method