Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis
- Conditions
- Non-alcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT03198572
- Lead Sponsor
- Fudan University
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Berberine Lifestyle intervention Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention. Placebo Placebo Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention. Placebo Lifestyle intervention Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention. Berberine Berberine Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
- Primary Outcome Measures
Name Time Method Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS) 48 weeks 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.
- Secondary Outcome Measures
Name Time Method Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning 48 weeks 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.
Change in serum cytokeratin 18 (CK-18) in U/L 48 weeks serum cytokeratin 18 (CK-18) in U/L
Improvement in liver histological fibrosis staging 48 weeks 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.
Change in anthropometric measures 48 weeks including BMI etc
Change in blood biochemistry 48 weeks including serum aminotransferase levels etc
Resolution of NASH 48 weeks Resolution of NASH was defined as a diagnosis of no steatohepatitis at 48 weeks among those with possible or definite NASH at baseline.
Change in liver fat content 48 weeks liver fat content determined by 1H MRS (in part of clinical centers)
Trial Locations
- Locations (6)
Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Xinjiang Medical University
🇨🇳Urumqi, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Tianjin Third Central Hospital
🇨🇳Tianjin, China