The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.
This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.
placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks
Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks
Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
ACTIVE_NOT_RECRUITINGThe Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
RECRUITINGShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)
A separate system of scoring the histological features of nonalcoholic fatty liver disease (NAFLD) called the NAFLD Activity Score (NAS) was used. An improvement in histologic findings require an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.
Time frame: 48 weeks
Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning
NAFLD activity score (NAS) is composed of steatosis (scale of 0 to 3), lobular inflammation (scale of 0 to 3), hepatocellular ballooning (scale of 0 to 2). Alteration in each component of NAS is measured.
Time frame: 48 weeks
Improvement in liver histological fibrosis staging
Fibrosis staging was measured as following criteria: 0=none, 1=perisinusoidal or periportal fibrosis, 2=perisinusoidal and portal/periportal fibrosis, 3=bridging fibrosis, and 4=cirrhosis.the definition of fibrosis stages improvement requires at least one stage.
Time frame: 48 weeks
Resolution of NASH
Resolution of NASH was defined as a diagnosis of no steatohepatitis at 48 weeks among those with possible or definite NASH at baseline.
Time frame: 48 weeks
Change in anthropometric measures
including BMI etc
Time frame: 48 weeks
Change in blood biochemistry
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
ACTIVE_NOT_RECRUITINGTianjin Third Central Hospital
Tianjin, China
ACTIVE_NOT_RECRUITINGXinjiang Medical University
Ürümqi, China
ACTIVE_NOT_RECRUITINGincluding serum aminotransferase levels etc
Time frame: 48 weeks
Change in liver fat content
liver fat content determined by 1H MRS (in part of clinical centers)
Time frame: 48 weeks
Change in serum cytokeratin 18 (CK-18) in U/L
serum cytokeratin 18 (CK-18) in U/L
Time frame: 48 weeks