Skip to content

Clinical study of combined application of Berberine hydrochloride tablets in the treatment of cholestatic liver disease

Clinical study of combined application of Berberine hydrochloride tablets in the treatment of cholestatic liver disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068536
Enrollment
Unknown
Registered
2023-02-22
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

cholestatic liver disease

Interventions

Experimental group:Take berberine hydrochloride tablets at a fixed dose of 0.2 g before meals.
Control group:N/A

Sponsors

Department of Gastroenterology, Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients over the age of 18 with a definite diagnosis of cholestatic liver disease (ALP >= 1.5 times the upper limit of the normal value, GGT >= 3 times the upper limit of the normal value); 2. Willing to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Have used microecological agents within 14 days before joining the group; 2. Chronic infections (such as tuberculosis, HIV infection and parasitic infection); 3. Neurological or mental diseases that hinder the effective implementation of informed consent or may interfere with the subjects' compliance with research procedures (for example, severe depression in the last two years, history of suicidal behavior in the last three months, etc.); 4. History of other mental diseases, including schizophrenia and bipolar disorder; 5. Patients who are allergic to berberine hydrochloride tablets and patients with hemolytic anemia; 6. Children with inherited glucose 6- phosphate dehydrogenase deficiency; 7. Pregnancy and lactation; 8. Those who have not signed the informed consent form and/or the research process has not been completely completed.

Design outcomes

Primary

MeasureTime frame
The neurotransmitter serotonin in the serum;The neurotransmitter serotonin in the serum;

Secondary

MeasureTime frame
Metabolites in faeces;

Countries

China

Contacts

Public ContactYang Shiming

The Second Affiliated Hospital of Army Medical University

383124847@qq.com+86 132 2868 6589

Outcome results

None listed

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