Skip to content

Berberine Regression Hepatitis B related fibrosis:a prospective randomized controlled study

Berberine Regression Hepatitis B related fibrosis:a prospective randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023426
Enrollment
Unknown
Registered
2019-05-27
Start date
2019-06-15
Completion date
Unknown
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B related fibrosis

Interventions

Control group:None
Intervention group:Berberine

Sponsors

Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 70 years, male or female. 2) Patients with HBsAg positive for more than 6 months, and currently HBsAg positive and / or serum HBV DNA = 500 copies / ml; 3)Regular use of antiviral drugs for more than a year 4) Real-time two-dimensional shear wave elastography Liver fibrosis stage F2-F4 was evaluated by liver stiffness (LSM) of 2D SWE.

Exclusion criteria

Exclusion criteria: 1) Patients who are unable or unwilling to sign an informed consent form; 2) Patients with hepatitis C, alcohol and nonalcoholic fatty liver disease, autoimmune liver disease, hereditary metabolic liver disease, various biliary system diseases, hepatobiliary parasitic diseases; 3) There are other systems with serious chronic diseases,including heart, kidney function and other organ dysfunction or history of malignant tumors; 4) Berberine drug contraindications: patients with hemolytic anemia and patients with glucose-6-phosphate dehydrogenase deficiency; 5) Patients with severe hepatorenal syndrome; 6) Pregnant or lactating women or patients who have a pregnancy plan and are unwilling to contraception during the study period; 7) Patients who can not use drugs according to regulations, poor compliance; 8) Patients who have been participating in other drug clinical trials for nearly half a year.

Design outcomes

Primary

MeasureTime frame
liver stiffness;Assessment of liver tissue inflammation;Evaluation of liver fibrosis;

Secondary

MeasureTime frame
Child-Pugh;Meld;

Countries

China

Contacts

Public ContactXiaoying Wu

Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University

xiaoyingwu2014@hotmail.com+86 18665633687

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026