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Clinical Study on Treatment of Acute-on-Chronic Liver Failure by Combination of Traditional Chinese and Western Medicine based on Spleen-strengthening Method

A Study on the Integrated Traditional Chinese and Western Medicine Treatment Plan Based on the Spleen-Strengthening Method for Acute-on-Chronic Liver Failure + Excellence Parallel Project 7

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002322
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Hepatitis B Virus-Related Acute-on-Chronic Liver Failure (HBV-ACLF)

Interventions

Western Medicine Treatment Group:Integrated Western Medicine Treatment
Integrated Traditional Chinese and Western Medicine Treatment Group (Jianpi Decoction + comprehensive Western medical treatment):Jianpi Formula + Western Medicine Comprehensive Treatment

Sponsors

Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Meeting the Western diagnostic criteria for early-to-mid-stage HBV-ACLF. (1) Aged 18–65 years male or female. (2) TCM syndrome differentiation confirming toxin-stasis conflict dampness-heat exuberance and spleen deficiency with vital qi depletion. (3) Signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Co-infection with other hepatitis viruses (HAV HEV HCV etc.). (2) Concurrent liver diseases including autoimmune hepatitis drug-induced liver injury alcoholic liver disease fatty liver disease or hereditary/metabolic liver disorders. (3) Active tuberculosis infection. (4) HIV-positive individuals. (5) Severe cardiac renal or other systemic comorbidities or other primary diseases affecting prognosis. (6) Patients with malignant tumors. (7) History of upper gastrointestinal bleeding. (8) Hepatorenal syndrome (HRS). (9) Pregnant or lactating women. (10) Patients with psychiatric disorders impairing compliance history of epilepsy or central nervous system diseases. (11) Late-stage HBV-ACLF. (12) Patients deemed ineligible by investigators.

Design outcomes

Primary

MeasureTime frame
Survival rate;—

Secondary

MeasureTime frame
Staging Changes in the Severity of Condition;Alanine Aminotransferase;Aspartate aminotransferase;Albumin;Total Serum Bilirubin;Prothrombin activity;Internationalization Standard Ratio;HBV-DNA viral load;Hepatitis B Surface Antigen;Hepatitis B Surface Antibody;Hepatitis B E antigen;Hepatitis B e antibody;Hepatitis B core antibody;Model for End-Stage Liver Disease score;Complication rate;Evaluation of therapeutic effects on TCM syndromes;—

Countries

China

Contacts

Public ContactFeng Ying

Beijing Ditan Hospital Capital Medical University

fengying@ccmu.edu.cn18610551462

Outcome results

None listed

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