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Clinical Study on Integrated Traditional Chinese and Western Medicine for Primary Biliary Cholangitis

Clinical Study on Integrated Traditional Chinese and Western Medicine for Primary Biliary Cholangitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000365
Enrollment
Unknown
Registered
2026-02-13
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Primary Biliary Cholangitis

Interventions

Group fatigue:YIQIJIANPI formulae
Group pruritus:LIANGXUEQUFENG formulae
Group xerostomia and xerophthalmia:ZIYINJIANPI formulae
Group abnormal liver function:QINGREJIEDUHUAYU formulae

Sponsors

Fifth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients with primary biliary cholangitis (PBC) who meet the criteria specified in the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2021) formulated by the Hepatology Society of the Chinese Medical Association. 2.Patients who are willing to participate in this study and sign the informed consent form. 3.Aged 18 to 75 years

Exclusion criteria

Exclusion criteria: 1.Patients with primary liver cancer; 2.Pregnant or lactating women; 3.Patients with other severe systemic diseases or mental disorders; 4.Patients positive for anti-HIV antibody; 5.Patients coinfected with hepatitis A, B, C, D, or E virus, cytomegalovirus (CMV), or Epstein-Barr virus (EBV); 6.Patients who have participated in other clinical trials within the past 3 months; 7.Patients with poor compliance or unwillingness to cooperate; 8.Patients with life-threatening complications at enrollment, including severe cerebral edema, grade 4 hepatic encephalopathy, refractory ascites, type 1 hepatorenal syndrome, or recurrent gastrointestinal bleeding; 9.Patients allergic to the traditional Chinese medicine (TCM) to be used; 10.Patients with acute-on-chronic liver failure (ACLF) or chronic liver failure (CLF).

Design outcomes

Primary

MeasureTime frame
liver fuction;

Secondary

MeasureTime frame
Fatigue Severity Scale;Visual Analog Scale;

Countries

China

Contacts

Public ContactGong Man

Fifth Medical Center of Chinese PLA General Hospital

gongman302@163.com13910123785

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026