Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT01965418
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria of chronic hepatitis B related liver fibrosis:
1. Age from 18 to 65 years old, male or female;
2. Consistent with the diagnosis criteria of chronic hepatitis B;
3. liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
4. TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
5. Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
6. Signed informed consent.
Exclusion Criteria:
1. liver fibrosis(Liver biopsy) stage F \<3 (Ishak);
2. Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
3. Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
4. Pregnant or lactating women;
5. Patients with allergic constitution or allergic to TCM used;
6. Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments;
7. Patients unsuitable for this trial in Researchers' consideration;
8. Co-infection with other viral liver disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01965418
Study Brief:
Protocol Section:
NCT01965418