Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

NCT03198572 | Unknown Phase 4

• 1 other identifier: 2016ZSLC04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.

Conditions

Non-alcoholic Steatohepatitis

Keywords

Non-alcoholic steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  48 weeks

Secondary Outcomes (7)

• Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning

  48 weeks

• Improvement in liver histological fibrosis staging

  48 weeks

• Resolution of NASH

  48 weeks

• Change in anthropometric measures

  48 weeks

• Change in blood biochemistry

  48 weeks

Study Arms (2)

Berberine

EXPERIMENTAL

Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.

Behavioral: Lifestyle intervention; Drug: Berberine

Placebo

PLACEBO COMPARATOR

Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.

Behavioral: Lifestyle intervention; Drug: Placebo

Interventions

Lifestyle intervention BEHAVIORAL

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.

Berberine; Placebo

Placebo DRUG

placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks

Placebo

Berberine DRUG

Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks

Berberine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, no limitation for ethnicity and gender.
• BMI is no more than 40 kg/m2.
• Patients with NASH based on liver biopsy obtained within 24 weeks before randomization. The histological evidence of NASH is defined as NAS ≥5 \[\] or NAS ≥4 with a minimum score of 1 for all of three components (steatosis, hepatocyte ballooning, and lobular inflammation), the diagnosis of NASH for EASYBEinNASH eligibility is based on reviews by three pathologists. If there are controversial pathologic diagnosis, at least 2 of the 3 pathologists are consistent with the pathologic diagnosis, which will be the final pathological diagnosis. If there are three different pathological diagnoses, it needs to be discussed and make a judgment by the chief pathologist to form the final pathology report.
• For patients with impaired glucose metabolism, one of the three following conditions needs to be met.
• ① For patients diagnosed as impaired glucose regulation, they will be treated with lifestyle intervention without hypoglycemic drugs;
• ② For patients diagnosed as diabetes and treated with hypoglycemic drugs, the treatment regimen should not be changed and the dosage should remain stable for more than 2 months before randomization;
• ③ For patients diagnosed as diabetes and treated with lifestyle intervention without hypoglycemic drugs, the treatment regimen should not be changed before randomization.
• All participants agree to sign the informed consent form.

You may not qualify if:

• Excessive alcohol intake ( \> 140 g per week for men and \>70 g per week for women within 6 months before enrollment);
• Liver enzymes (ALT or aspartate aminotransferase(AST) is 5 times higher than the upper limit of normal range;
• Liver diseases caused by other reasons, such as alcohol abuse, viral hepatitis, drugs, auto-immune hepatitis, hereditary liver disease, liver cirrhosis, liver cancer, etc;
• Biliary tract diseases, biliary obstructive disease, etc;
• Other diseases that affect glucose and lipid metabolism, such as hypothyroidism, hyperthyroidism, hypercortisolism, etc;
• Diabetic patients with poor blood glucose control: HbA1c \>9.5%;
• Use of drugs that may affect the outcome measures of this study 3 months before enrollment, including pioglitazone, GLP-1 receptor agonist, DPP-4 inhibitor, insulin, and glycyrrhizic acid preparation, etc;
• Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 2.0mg/dL (176.8umol/L);
• Life expectancy is no more than 5 years;
• Pregnant or planning to become pregnant within the next 64 weeks for female participant;
• Any situation that may affect the implementation or results of the study;
• Continuous use of drugs that may affect steatohepatitis 3 months before enrollment, such as glucocorticoids, methotrexate, etc;
• Subjects participated in other clinical trials in the past 4 weeks; The researchers did not think they were suitable for the study.

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• Tianjin Third Central Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Xinjiang Medical University: collaborator

Study Sites (6)

Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, China

ACTIVE NOT RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

RECRUITING

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

ACTIVE NOT RECRUITING

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

ACTIVE NOT RECRUITING

Tianjin Third Central Hospital

Tianjin, China

ACTIVE NOT RECRUITING

Xinjiang Medical University

Ürümqi, China

ACTIVE NOT RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Berberine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xin Gao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong-Mei Yan

CONTACT

8613761666976; yan.hongmei@zs-hospital.sh.cn

Ming-Feng Xia

CONTACT

8613611826871; xia.mingfeng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 26, 2017
• Study Start: August 16, 2017
• Primary Completion: December 30, 2023
• Study Completion: July 30, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)