Skip to content

The effect on clinical efficacy of primary biliary cholangitis with hepatic stagnation and spleen deficiency type and the distribution of intestinal flora through Drug Pair of Ginseng and Radix Bupleuri

The effect on clinical efficacy of primary biliary cholangitis with hepatic stagnation and spleen deficiency type and the distribution of intestinal flora through Drug Pair of Ginseng and Radix Bupleuri

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003795
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

primary biliary cholangitis

Interventions

Sponsors

Shanghai chinese medicine hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above western medicine diagnostic criteria, AMA titer > 1:40; Alkaline phosphatase (ALP) > 1.5 times the upper limit of normal value or glutamyl transpeptidase b> 5 ULN lasting for 24 weeks or more. (2) Patients who meet the criteria for syndrome differentiation of liver depression and spleen deficiency in Traditional Chinese medicine are between 18 and 70 years old, regardless of gender. (3) Informed consent, sign informed consent and volunteer for the study.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women. (2) Patients with viral hepatitis or other hepatotropic virus infection, alcoholic liver disease, drug-induced liver injury, primary ssclerosis cholangitis, autoimmune hepatitis, Buga syndrome, hematopathy, Wilson's disease and other liver diseases; (3) Had used methotrexate, azathioprine or glucocorticoid in the 3 months before enrollment; (4) Evidence of intrahepatic or extrahepatic biliary tract obstruction; (5) Patients with liver failure or hepatorenal syndrome at baseline or after liver transplantation; (6) Patients with serious heart, liver, kidney or other complications or complicated with liver cancer or other malignant tumors or other serious primary diseases; (7) Those who have taken antibiotics in recent 2 weeks.

Design outcomes

Primary

MeasureTime frame
Gamma-glutamyl transpeptidase;alkaline phosphatase;gut microbiota;

Countries

China

Contacts

Public ContactRuan Jun

Shanghai Chinese Medicine Hospital

ruanjuntcm@163.com+86 13817081905

Outcome results

None listed

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