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A multi-center, randomized, control study of Traditional Chinese Herbal multipath administration combined with entecavir in patients with HBV-related chronic-on-acute liver failure of early-middle satge

A multi-center, randomized, control study of Traditional Chinese Herbal multipath administration combined with entecavir in patients with HBV-related chronic-on-acute liver failure of early-middle satge

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009316
Enrollment
Unknown
Registered
2016-10-05
Start date
2017-02-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

HBV-related chronic-on-acute liver failure

Interventions

entecavir group:oral entecavir
Jieduzhuyu and entecavir group:Jieduzhuyu decotion enema and oral entecavir
Xiaohuang decotion, Jieduzhuyu and entecavir group:Oral Xiaohuang decotion, Jieduzhuyu decotion enema and oral entecavir

Sponsors

Shanghai Public Health Clinical Center, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18~65 years old; 2. patients diagnosed as HBV-related chronic-on-acute liver failure of early-middle satge; 3. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with gastrointestinal bleeding and/or hepatic encephalopathy over level 3, those who failed to tolerate oral TCM decotion and/or TCM enema; 2. Patients with severe cardiovascular diseases, kidney diseases, hematologic diseases, lung diseases (asthma, COPD), autoimmnue diseases or other conditions influencing survival including cancer or AIDS; 3. Women who are breastfeeding, pregnancy or are preparing for pregnancy; 4. Patients without capacity for civil conduct or limited capacity; 5. Patients who have a history of alcohol abuse and/or drug abuse; 6. Those who are allergic to the constituents of the test drug and those who are allergic; 7. Patients who have participated in other clinical trials in the past 3 months; 8. Those who are not appropriate to participate in the trial evaluated by researchers.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Secondary

MeasureTime frame
liver function tests;prothrombin time;prothrombin activity;

Countries

China

Contacts

Public ContactXiaorong Chen

Shanghai Public Health Clinical Center, Fudan University

xiaorong3chen@163.com+86 18930817533

Outcome results

None listed

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