Skip to content

Clinical study of Yiqi Huoxue Jiedu Fang in the treatment of chronic hepatitis B with nucleos(t)ide analogues and reducing the recurrence of drug withdrawal

Clinical study of Yiqi Huoxue Jiedu Fang in the treatment of chronic hepatitis B with nucleos(t)ide analogues and reducing the recurrence of drug withdrawal

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064736
Enrollment
Unknown
Registered
2022-10-15
Start date
2022-10-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Chronic Hepatitis B

Interventions

Experimental group:Nucleos(t)ide analogues+Concentrated Pills of Yiqi Huoxue Jiedu
Control group:Nucleos(t)ide analogues

Sponsors

Shenzhen Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Previously met the antiviral treatment standards and has been using NAs antiviral therapy for over 48 weeks; 2. Present serum HBsAg (+) and HBsAg<1500IU/ml, HBeAg positivity obtained HBeAg seroconversion after NAs treatment, and serum HBV DNA<20IU/ml; 3. There are three or more consecutive follow-up records within one year, with follow-up intervals exceeding one month, and the ALT levels are all within the normal range (<40U/L); 4. Aged between 18 and 65 years old; 5. Agree to participate in this study and personally sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. HBsAg negative; 2. NAs were HBeAg negative before treatment; 3. Simultaneously infected with HIV, HAV, HCV, HDV, and HEV; 4. Concomitant liver cirrhosis, metabolic or autoimmune liver disease; 5. Tumor patients; 6. Individuals with mental illness and other serious organ diseases; 7. Pregnant or lactating women, or those who have a pregnancy plan within one year; 8. History of alcohol or illegal drug abuse; 9. Patients who have participated in other experimental studies 30 days prior to enrollment; 10. Failure to comply with research regulations; 11. Patients with allergies to any drug or component in this study.

Design outcomes

Primary

MeasureTime frame
The proportion of patients who discontinued the drug after 48 weeks treatment;

Secondary

MeasureTime frame
HBsAg;HBV RNA;HBcrAg;CD4+ T cell;CD8+ cell;CD4+ /CD8+;

Countries

China

Contacts

Public ContactJinsong He

Shenzhen Traditional Chinese Medicine Hospital

hjsprayforyou@sina.com+86 13632661228

Outcome results

None listed

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