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To Explore the Immunomodulatory Effect and Efficacy Evaluation of Qushi Jiedu Huayu Decoction in Patients with Acute-on-Chronic Liver Failure Based on the Pathogenesis Theory of "Dampness-Toxin-Stasis"

To Explore the Immunomodulatory Effect and Efficacy Evaluation of Qushi Jiedu Huayu Decoction in Patients with Acute-on-Chronic Liver Failure Based on the Pathogenesis Theory of "Dampness-Toxin-Stasis"

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002300
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-12-01
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

Acute-on-Chronic Liver Failure

Interventions

Western medicine treatment group:no
Integrated Traditional Chinese and Western Medicine Treatment Group:Oral traditional Chinese medicine (TCM) intervention

Sponsors

The Third Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

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

MeasureTime frame
Alanine Aminotransferase; Aspartate Aminotransferase; Total Serum Bilirubin;Prothrombin Time;International Normalized Ratio;

Secondary

MeasureTime 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

Public ContactYuan Ouyang

The Third Affiliated Hospital of Zhejiang Chinese Medical University

1275790794@qq.com17816088762

Outcome results

None listed

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