Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Consistent with the diagnosis criteria of chronic hepatitis B;
TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
...
Consistent with the diagnosis criteria of chronic hepatitis B;
TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
Signed informed consent.
liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
Age from 18 to 65 years old, male or female;

Exclusion Criterias

Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
Patients with allergic constitution or allergic to TCM used;
liver fibrosis(Liver biopsy) stage F <3 (Ishak);
...
Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
Patients with allergic constitution or allergic to TCM used;
liver fibrosis(Liver biopsy) stage F <3 (Ishak);
Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
Pregnant or lactating women;
Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments;
Patients unsuitable for this trial in Researchers' consideration;
Co-infection with other viral liver disease.

Summary

Conditions
  • Chronic Hepatitis B
  • Liver Fibrosis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criterias

Consistent with the diagnosis criteria of chronic hepatitis B;
TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
...
Consistent with the diagnosis criteria of chronic hepatitis B;
TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
Signed informed consent.
liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
Age from 18 to 65 years old, male or female;

Exclusion Criterias

Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
Patients with allergic constitution or allergic to TCM used;
liver fibrosis(Liver biopsy) stage F <3 (Ishak);
...
Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
Patients with allergic constitution or allergic to TCM used;
liver fibrosis(Liver biopsy) stage F <3 (Ishak);
Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
Pregnant or lactating women;
Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments;
Patients unsuitable for this trial in Researchers' consideration;
Co-infection with other viral liver disease.

Locations

Beijing, Beijing, 100039
Beijing, Beijing, 100039

Tracking Information

NCT #
NCT01965418
Collaborators
Not Provided
Investigators
  • Principal Investigator: Yongping Yang, Master Beijing 302 Hospital
  • Yongping Yang, Master Beijing 302 Hospital