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The multicenter clinical study of TCM in the prevention of HBV-related hepatic cirrhosis

The multicenter clinical study of TCM in the prevention of HBV-related hepatic cirrhosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036878
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-02
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Macronodular cirrhosis after chronic hepatitis B

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis B cirrhosis who meet the diagnostic criteria; 2. Hepatic regenerative nodules (>5 mm) were detected by Contrast enhanced ultrasound; 3. Aged 18 to 65 years; 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with cirrhosis caused by other hepatophilic virus infection or other pathogenic factors; (2) The presence or suspected presence of primary hepatocellular carcinoma lesions was detected by B-mode ultrasonography or MRI; (3) The patients with Child-Pugh C grade > 12 points, had upper gastrointestinal bleeding, hepatic encephalopathy and hepatorenal syndrome in the past six months; (4) Patients with severe primary diseases of heart, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract; or psychiatric patients; (5) Pregnant women or breast-feeding women who are willing to have children in the near future.

Design outcomes

Primary

MeasureTime frame
Incidence of primary liver cancer;Incidence and mortality of severe hepatitis;Incidence of upper gastrointestinal hemorrhage, hepatic encephalopathy and hepatorenal syndrome;

Secondary

MeasureTime frame
Virological indicators;Liver function;CBC;Alpha fetoprotein;Contrast enhanced ultrasound;Fibroscan;TCM Syndrome Scale and Quality of Life Scale;

Countries

China

Contacts

Public ContactGao Yueqiu

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

gaoyueqiu@hotmail.com+86 13795388789

Outcome results

None listed

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