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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509418

Enrollment

Registered

2007-07-31

Start date

2007-02-28

Completion date

2007-09-30

Last updated

2009-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic steatohepatitis, Nonalcoholic Fatty Liver, Nutritional supplement, Diet, Exercise

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTViusid

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

OTHERHypocaloric Diet with controlled exercise

Modified ADA diet in combination with controlled exercise daily 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).	24 weeks

Secondary

Measure	Time frame
Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)	24 weeks

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026