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Randomized Controlled Clinical Study on Improving Recompensation Rate in Decompensated Hepatitis B Cirrhosis Using Effective Proven Formulas Based on Core Pathogenesis

Randomized Controlled Clinical Study on Improving Recompensation Rate in Decompensated Hepatitis B Cirrhosis Using Effective Proven Formulas Based on Core Pathogenesis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000110
Enrollment
Unknown
Registered
2026-01-17
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Decompensated Hepatitis B Cirrhosis

Interventions

Yangyin Huoxue Lishui Formula Control Group:Yangyin Huoxue Lishui Formula Placebo + Standard Conventional Treatment Group
Yangyin Huoxue Lishui Formula Treatment Group:Yangyin Huoxue Lishui Formula + Standard Conventional Treatment Group
Xiaozhang Formula Treatment Group:Xiaozhang Formula + Standard Conventional Treatment Group
Xiaozhang Formula Control Group:Xiaozhang Formula Placebo + Standard Conventional Treatment Group

Sponsors

The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for decompensated hepatitis B cirrhosis as outlined above; 2) Meet the TCM syndrome diagnostic criteria for spleen deficiency with water retention combined with static heat interminglement (Xiaozhang Formula group) or for liver-kidney yin deficiency combined with blood stasis and water diffusion (Yangyin Huoxue Lishui Formula group); 3) Age between 18 and 65 years, regardless of gender; 4) Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1) Suspected hepatocellular carcinoma; 2) Concomitant other liver diseases; 3) History of variceal bleeding (VB), hepatic encephalopathy (HE), hepatorenal syndrome, or hepatopulmonary syndrome within the past 6 months; 4) ALT = 5×ULN, or AST = 5×ULN, or TBil = 3×ULN, or Scr = 1.5×ULN; 5) Concurrent dysfunction of other organs or malignant tumors; 6) Pregnant or lactating women, or individuals planning for pregnancy in the near future; 7) Severe mental illness; 8) Participation in other drug clinical trials within 3 months prior to screening.

Design outcomes

Primary

MeasureTime frame
Recompensation rate in decompensated cirrhosis;—

Secondary

MeasureTime frame
Decompensation rate of cirrhosis;Incidence of Hepatocellular Carcinoma;Liver disease-related mortality;Improvement rate in Child-Pugh (CTP) score;Improvement rate in the Model for End-Stage Liver Disease (MELD) score;Improvement in TCM symptoms;—

Countries

China

Contacts

Public ContactWang Jing

The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

lywj1968@126.com13882726162

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026