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Vitamin E Versus Placebo for the Treatment of Non Diabetic Patients With Nonalcoholic Steatohepatitis

NCT02962297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-04-03

No results posted yet for this study

Summary

VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults with NASH compared to treatment with placebo in China.

Conditions

  • NASH (Non-Alcoholic Steatohepatitis)

Interventions

DRUG

Vitamin E softgel

All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).

DRUG

Placebo

All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise). Height and weight, waist-to-hip ratio Review of diet and exercise

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • The Affiliated Hospital of Hangzhou Normal University

    collaborator OTHER

  • Zhejiang Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junping Shi, Phd · The Affiliated Hospital of Hangzhou Normal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-11-09
Completion
2021-12-17

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT02962297 on ClinicalTrials.gov