Skip to content

Clinical study of Huangqi Guizhi Wuwu Decoction combined with ursodeoxycholic acid in the treatment of primary biliary cholangitis

Clinical study of Huangqi Guizhi Wuwu Decoction combined with ursodeoxycholic acid in the treatment of primary biliary cholangitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063119
Enrollment
Unknown
Registered
2022-08-31
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Primary biliary cholangitis (PBC)

Interventions

Intervention group:Huangqi Guizhi Wuwu Decoction+UDCA
Control group:UDCA

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and < 75 years. 2. Patients with primary PBC who have been clearly diagnosed. 3. Take UDCA continuously for no more than 3 months. 4. Voluntarily participate in the study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Antibiotics have been taken in the last 2 months. 2. In recent 2 months, I have taken intestinal microecological preparations. 3. History of drinking within the last 3 months. 4. History of inherited metabolic diseases, viral hepatitis, cirrhosis, liver cancer and other liver diseases. 5. Infectious diarrhea, chronic diarrhea, irritable bowel syndrome, inflammatory diseases and other intestinal diseases. 6. Pregnant and lactating patients. 7. Patients with severe mental illness, drug abuse, alcohol abuse, etc., who could not cooperate with the study were included. 8. Participated in any other clinical investigator within 1 month prior to screening (visit). 9. At the time of screening (visit), newly diagnosed patients have been taking UDCA for more than one month. 10. Patients with any other diseases or conditions that the investigator determined were not eligible for participation in the study.

Design outcomes

Primary

MeasureTime frame
quality of life scale;UDCA biochemical response rate;alkaline phosphatase (ALP);?-glutamyltransferase(GGT);

Secondary

MeasureTime frame
human type III procollagen peptide;serum type IV collagen;serum laminin;serum hyaluronidase;

Countries

China

Contacts

Public ContactYu Kui

Longhua Hospital Shanghai University of Traditional Chinese Medicine

yukuitcm@shutcm.edu.cn+86 13761167755

Outcome results

None listed

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