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Consolidation treatment of Chinese herbal medicine plus entecavir for chronic hepatitis B to reduce off-therapy recurrence: a randomized controlled trial

Chinese herbal compound combined with entecavir to reduce the off-therapy recurrence rate in HBeAg-positive chronic hepatitis B patients: a multi-center, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021232
Enrollment
Unknown
Registered
2019-02-02
Start date
2019-02-11
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

HBeAg-positive Chronic hepatitis B

Interventions

Experiment group:Chinese herbal medicine (Tiaogan Buxu Jiedu granule) 1 dose/day plus entecavir 0.5 mg/day, oral administration
Control group:Chinese herbal medicine placebo (placebo of Tiaogan Buxu Jiedu granule) 1 dose/day plus entecavir 0.5 mg/day, oral administration

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Those who meet all the following criteria will be included: 1. Previously diagnosed with HBeAg-positive chronic hepatitis B (CHB), achieved HBeAg loss or seroconversion after nucleos(t)ide analogues (NUCs) treatment, and regularly taking NUCs at the time of admission; 2. Aged 18 to 65 years; 3. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: Any of the following cases will be excluded: 1. Diagnosed with chronic hepatitis caused by non-viral causes, overlapped virus infections, or cryptogenic hepatitis; 2. Accompanied by liver failure, hepatocirrhosis (including stage 4 fibrosis), hepatic encephalopathy, electrolyte disorders, gastrointestinal bleeding, fatal infections or any other severe complications; 3. Diagnosed with malignant tumors or with a progressive elevation of serum tumor markers; 4. Diagnosed with primary or secondary cardiovascular, cerebrovascular, pulmonary, renal, endocrine, nerve and hematology diseases; 5. Participating or participated in other clinical trials within one month; 6. Diagnosed mental disorders; 7. Confirmed Hepatitis B virus Pre C/C or P gene variants; 8. Pregnant or lactating women, individuals that are scheduled to conceive or fertilize; 9. With other unfavorable situations.

Design outcomes

Primary

MeasureTime frame
Virus serological indexes: HBsAg HBsAb HBeAg HBeAb HBcAb;HBV DNA;—

Secondary

MeasureTime frame
Liver function;—

Countries

China

Contacts

Public ContactYong‘an Ye

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

yeyongan2012@163.com+86 010 84013206

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026