Trial | NCT00509418  Report issue

Title

Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis
Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Viusid ...

  • Study Participants

    60
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.
Study Started
Feb 28
2007
Primary Completion
Sep 30
2007
Study Completion
Sep 30
2007
Last Update
Jan 12
2009
Estimate

Dietary Supplement Viusid

Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks

  • Other names: Nutritional supplement

Other Hypocaloric Diet with controlled exercise

Modified ADA diet in combination with controlled exercise daily 24 weeks

  • Other names: lifestyle modification

A Experimental

Viusid, a nutritional supplement, in combination with controlled diet and exercise

B Active Comparator

Controlled diet and exercise

Criteria 

Inclusion Criteria:

Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
Age between 18 and 70 years
Ability to provide informed consent
Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria:

Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
Pregnancy or lactation
Decompensated cirrhosis
Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter)
Contraindication to liver biopsy
Refusal to participate in the study
Concomitant disease with reduced life expectancy
Severe psychiatric conditions
Drug dependence
No Results Posted