An open, randomized blank controlled clinical trail on Total glucosides of paeony for PBC with AIH features

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17012813

Enrollment

Unknown

Registered

2017-09-26

Start date

2017-09-25

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

PBC with AIH features

Interventions

1:UDCA

2:UDCA+Total glucosides of paeony

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-75 years; (2) Diagnosed with definite PBC, not fulfiling PBC-AIH overlap syndrome according to Paris criteria, but should satisfy high levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(>3 X ULN) and/or high levels of IgG(>1.3 X ULN) and without moderate or severe periportal or periseptal lymphocytic piecemeal necrosis on liver biopsy; (3) Agreed to participate in the trial, and assigned informed consent.

Exclusion criteria

Exclusion criteria: 1. The presence of hepatitis A, B, C, D, or E virus infection; 2. Patients with presence of decompensated cirrhosis; 3. Patients with presence of fulminant liver failure; 4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease. 5. Pregnant and breeding women; 6. Severe disorders of other vital organs, such as severe heart failure, cancer; 7. Parenteral administration of blood or blood products within 6 months before screening; 8. Recent treatment with drugs having known liver toxicity; 9. Taken part in other clinic trials within 6 months before enrollment.

Design outcomes

Secondary

Measure	Time frame
ALP;GGT;ALT;AST;globin;IgG;response rate;clinical symptoms;Side effects;total bilirubin;	—

Countries

China

Contacts

Public ContactLi Yang

West China Hospital, Sichuan University

yangli_hx@scu.edu.cn+86 18680601276

Outcome results

None listed

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