Acute-on-Chronic Liver Failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Referring to the Guidelines for the Diagnosis and Treatment of Liver Failure formulated by the Liver Failure and Artificial Liver Group of the Infectious Diseases Society of Chinese Medical Association and the Severe Liver Disease and Artificial Liver Group of the Hepatology Society of Chinese Medical Association in 2018. (1) Meet the Western medicine diagnostic criteria for ACLF;(2) Meet the TCM diagnostic criteria and be differentiated as Toxin-Heat-Stasis Binding Syndrome or Damp-Heat Accumulation Syndrome;(3) Have not received traditional Chinese medicine (TCM) or related drugs within 2 weeks before enrollment;(4) Aged between 20 and 75 years (including 20 and 75 years), regardless of gender;(5) Voluntarily participate in this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Referring to the TCM Clinical Guidelines for the Diagnosis and Treatment of Acute-on-Chronic Liver Failure and Guidelines for the Diagnosis and Treatment of Jaundice issued by the China Association of Chinese Medicine, and combined with clinical practice, the following is formulated. (1) Patients with acute liver failure, subacute liver failure, or chronic liver failure;(2) Patients with tumors; patients with severe impairment of organ functions such as heart, brain, kidney, or hematological system, or patients with mental illness; or patients with other diseases that may cause intestinal flora imbalance;(3) Patients taking immunosuppressants for a long time;(4) Patients with a history of abdominal surgery such as liver transplantation or partial gastrointestinal resection;(5) Lactating or pregnant women;(6) Patients with poor compliance;(7) Patients who have participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase; Aspartate Aminotransferase; Total Serum Bilirubin;Prothrombin Time;International Normalized Ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Albumin;Serum Creatinine;Serum Immunoglobulin A; Immunoglobulin G; Immunoglobulin M;CD4+ T Lymphocyte Count;CD8 +T Lymphocyte Count;C-Reactive Protein;Procalcitonin;Interleukin-1;Interleukin-6;Interleukin-10; Tumor Necrosis Factor-a; | — |
Countries
China
Contacts
The Third Affiliated Hospital of Zhejiang Chinese Medical University