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Study for Optimized protocol of Traditional Chinese Medicine in the Treatment of Chronic Hepatitis B Virus Carriers

Study for Optimized protocol of Traditional Chinese Medicine in the Treatment of Chronic Hepatitis B Virus Carriers

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026172
Enrollment
Unknown
Registered
2019-09-24
Start date
2018-01-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Chronic Hepatitis B

Interventions

Sponsors

Shenzhen Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients meet the diagnostic criteria for chronic HBV carriers (1) serum HBsAg, HBeAg and HBV-DNA are positive; (2) patients are fluped 3 times in one year, whose serum ALT, AST are within the normal range; (3) Fibroscan10^5 IU/ml, <10^9 IU/ml; 6. Histological Knodell HAI<4 score, Ishak<=3 score, or Fibroscan<7.0 kPa; 7. Patient sign the informed consents and volunteer to participate in this clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients infect HIV, HCV and HDV; 2. Patients with metabolic or autoimmune liver disease; 3. Patients have a history of alcohol abuse or illicit drugs or participate in other clinical trials of hepatitis drugs within 30 days; 4. Serum ALT and AST levels show abnormality with one years; 5. Patients are treated with nucleoside or interferon for 24 weeks prior to enrollment; 6. Inactive HBsAg carriers; 7. Patients with cirrhosis or patients' AFP are increased; 8. Pregnant or lactating women; 9. Patients with mental disease and other serious organ diseases.

Design outcomes

Primary

MeasureTime frame
Serum HBsAg;Serum HBeAg;Serum HBV-DNA;

Secondary

MeasureTime frame
AFP;Fibroscan;Color Doppler ultrasound examination;Knodell HAI;Ishak;

Countries

China

Contacts

Public ContactGuangdong Tong

Shenzhen Traditional Chinese Medicine Hospital

tgd755@163.com+86 0755 23984646

Outcome results

None listed

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