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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
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
Beijing Ditan Hospital Capital Medical University
Beijin, Beijing Municipality, China
302 Military Hospital of China
Beijing, China
Beijing YouAn Hospital Capital Medical Univercity
Improvement in hepatic histology
Improvement in hepatic histology after 96 weeks of treatment as determined by liver biopsies compared to baseline. (Independent pathological evaluation committee was charged with interpreting of the histological characteristic and that allows for assessment of changes with therapy). The definition of histologic improvement requires all three of the following criteria: ① either improvement in NAS by at least 2 points or post-treatment NAS of 3 points or less, ② at least 1 point improvement in the score for ballooning or lobular inflammation③ no worsening of fibrosis stages.
Time frame: after 96 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing, China
West China Hospital, Sichuan university
Chengdu, China
The first Affiliated Hospital, Sun Yat-sen University
Guangdong, China
Guangdong Provincial Chinese Medicine Hospital
Guangzhou, China
Nanfang Hospital
Guangzhou, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
Southwest Medical University Affiliated
Luzhou, China
The Second Hospital of Nanjing
Nanjing, China
...and 5 more locations