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Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

NCT00509418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-01-12

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Viusid

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

OTHER

Hypocaloric Diet with controlled exercise

Modified ADA diet in combination with controlled exercise daily 24 weeks

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Adelaida Rodríguez de Miranda, MD · National Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Cuba

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509418 on ClinicalTrials.gov