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NCT03577938
Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment
NA trial testing Chinese herbal medicine in Acute on Chronic Liver Failure in 516 participants. Completed in 30 June 2021.
30 June 2021
Quick facts
| Lead sponsor | Beijing 302 Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 516 |
| Start date | 10 January 2019 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 15 locations across China |
Drugs / interventions tested
- Chinese herbal medicine
- Control (blank)
Conditions studied
- Acute on Chronic Liver Failure — all drugs for Acute on Chronic Liver Failure →
- Traditional Chinese Medicine — all drugs for Traditional Chinese Medicine →
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
Beijing 302 Hospital
Who can join
Adults 16 to 65, any sex, with Acute on Chronic Liver Failure or Traditional Chinese Medicine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute deterioration in the setting of chronic liver disease associated with high short-term mortality. Currently, there is no specific treatment for patients with ACLF. Our previous results showed that Chinese herbal medicine (CHM) could reduce the mortality rate and the incidence of complications of ACLF effectively. In this study, we aim to conduct the multi-center randomized controlled trial to evaluate the effect of unified CHM formulas and provide propagable and high-level evidence for clinical practice. Methods/design: This is a prospective, multicenter, centrally randomized controlled trial. Five hundred and ten patients diagnosed with HBV-related ACLF will be allocated in a 1:1 ratio to SMT group (standard medical therapy) and CHM group (CHM and SMT). The primary outcome is the transplant-free mortality rates at week 4, 8, 12, 24 and 48. Secondary outcomes include (1) the incidence of adverse reactions, (2) influence on liver function, (3) the incidence of serious complications and (4) the level of inflammatory cytokines. Discussion: The effectiveness and safety of CHM formulas are assessed in the treatment of ACLF.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Gut microbiota mediated molecular events and therapy in liver diseases.
Qi X, Yang M, Stenberg J, Dey R, et al · · 2020 · cited 20× · PMID 33505139 · DOI 10.3748/wjg.v26.i48.7603
Verify or expand the search:
- PubMed search for NCT03577938
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03577938 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing 302 Hospital
- Last refreshed: 31 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03577938.
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