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Clinical efficacy observation of TCM in the prevention and treatment of macronodular cirrhosis (precancerous lesions)

Clinical efficacy observation of TCM in the prevention and treatment of macronodular cirrhosis (precancerous lesions)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002313
Enrollment
Unknown
Registered
2019-05-03
Start date
2019-05-10
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

macronodular cirrhosis

Interventions

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with chronic hepatitis B cirrhosis who meet the diagnostic criteria; 2.Hepatic regenerative nodules (> 3 mm) were detected by B-mode ultrasonography and MRI. 3.Age ranges from 18 to 65 years, gender is not limited. 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 and MRI. (3) The patients with decompensated cirrhosis, such as those with Child-Pugh C grade > 12 points, had upper gastrointestinal bleeding, hepatic encephalopathy, intractable ascites, hemorrhagic tendency, hepatorenal syndrome and primary hepatocellular carcinoma 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 and mortality of severe hepatitis;Incidence of primary liver cancer;Incidence of upper gastrointestinal hemorrhage, hepatic encephalopathy and hepatorenal syndrome;

Secondary

MeasureTime frame
CBC;Virological indicators;Ultrasound/MRI of Upper Abdomen;TCM Syndrome Scale and Quality of Life Scale;Alpha fetoprotein;Fibroscan;Liver function;

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