protocolSection identificationModule nctId: NCT06371196, orgStudyIdInfo id: BBD-PBC 2024-03, briefTitle: Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-07-25, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mei Han, class: OTHER, descriptionModule briefSummary: 1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin., conditionsModule conditions: Primary Biliary Cholangitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Babaodan Capsule, outcomesModule primaryOutcomes measure: Total bilirubin (TBil) reversion rate, primaryOutcomes measure: Total bilirubin (TBil) efficacy rate, secondaryOutcomes measure: biological response rate, secondaryOutcomes measure: ALT, secondaryOutcomes measure: AST, secondaryOutcomes measure: ALP, secondaryOutcomes measure: TBA, secondaryOutcomes measure: DBil, secondaryOutcomes measure: IBil, secondaryOutcomes measure: 5-D Pruritus Scale Score, secondaryOutcomes measure: Fatigue section of the PBC-40 questionnaire, secondaryOutcomes measure: Immunological indicators - serum IgM, secondaryOutcomes measure: Immunological indicators - serum IgG, secondaryOutcomes measure: Immunological indicators - serum IgA, secondaryOutcomes measure: Immunological indicators - anti-gp210 antibody, secondaryOutcomes measure: Immunological indicators - anti-sp100 antibody, secondaryOutcomes measure: Immunological indicators - autoantibodies AMA/AMA-M2, secondaryOutcomes measure: Histopathology of the liver - grading of inflammatory activity, secondaryOutcomes measure: Histopathology of the liver - staging of the degree of fibrosis, secondaryOutcomes measure: 12-lead electrocardiogram, secondaryOutcomes measure: Physical examination, secondaryOutcomes measure: Routine blood test, secondaryOutcomes measure: Renal Function Tests-BUN, secondaryOutcomes measure: Renal Function Tests-UA, secondaryOutcomes measure: Renal Function Tests-Scr, secondaryOutcomes measure: Urinalysis, secondaryOutcomes measure: Coagulation tests-PT, secondaryOutcomes measure: Coagulation tests-APTT, secondaryOutcomes measure: Coagulation tests-TT, secondaryOutcomes measure: Coagulation tests-FIB, secondaryOutcomes measure: Urine beta-hCG pregnancy test, secondaryOutcomes measure: adverse event, secondaryOutcomes measure: Body temperature, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Number of breaths in 1 min, secondaryOutcomes measure: Blood pressure-Diastolic blood pressure(mmHg), secondaryOutcomes measure: Blood pressure-Systolic blood pressure(mmHg), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False