Jaundice
Conditions
Interventions
Non exposed group:During the routine treatment process, Babao Dan capsules were not used, and no Babao Dan capsules were taken during the treatment process in the first month before enrollment.
exposed group:During routine treatment, use Babao Dan capsules for a course of at least 7 days
Among them, Babao Dan capsules are taken orally, 0.6 grams per time, 3 times per day.
Sponsors
Beijing Hospital of Traditional Chinese MedicineCapital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male or female age = 18 years old = 85 years old. 2. Diagnosed with jaundice caused by one or more of the following liver diseases including drug-induced liver disease alcoholic liver disease viral liver disease primary biliary cholangitis (PBC) primary sclerosing cholangitis (PSC) IgG4 associated sclerosing cholangitis (IgG4 SC) autoimmune hepatitis (AIH) PBC-AIH overlap syndrome and non-alcoholic fatty liver disease. 3. Clinical manifestations of jaundice mainly characterized by yellow eyes yellow urine and yellow body; Serum total bilirubin: 1.5 × ULN = TBiL = 5 × ULN; 4. Patients who have a treatment course of = 7 days have serum liver function test data before and after treatment for efficacy evaluation comparison and have not changed their jaundice treatment plan during the two liver function tests. 5. The patient voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. In addition to being included in the standard disease categories jaundice caused by other reasons including but not limited to: bile duct stones various tumors such as pancreatic biliary and ampullary cancers liver cancer genetic metabolic liver disease and intrahepatic cholestasis during pregnancy. 2. Previously suffered from ascites esophageal and gastric variceal bleeding hepatic encephalopathy decompensated liver function (Child Pugh grade C) spontaneous bacterial peritonitis or liver transplantation or planned liver transplantation; 3. Merge severe primary diseases such as blood system (various severe anemia hemophilia etc.) kidney disease (chronic kidney disease renal insufficiency etc.) respiratory system (active pulmonary tuberculosis severe lung infections etc.) digestive system (active gastrointestinal ulcers refractory colitis etc.) nervous system and mental illness (including a history of mental illness or a family history of mental illness); 4. Currently receiving anticoagulant therapy (such as warfarin heparin etc.); 5. The following laboratory test abnormalities exist: (1) glomerular filtration rate (eGFR)10 times ULN; 6. Pregnant planned pregnant and lactating women who have the ability to conceive during the study period but are unwilling to use effective contraceptive measures (= 1 effective contraceptive method such as condoms hormonal contraceptives intrauterine devices) or male subjects who are unwilling to use contraceptive measures; 7. Patients with infectious diseases such as HIV and syphilis who are deemed unsuitable for inclusion by researchers; 8. Any other disease or condition that interferes with drug absorption distribution metabolism or excretion (such as patients with inflammatory bowel disease or those who have undergone gastric bypass surgery); 9. Individuals with mental instability or limited behavioral abilities; 10. Suffering from malignant tumors in the past 5 years regardless of whether treatment has been received and whether there is evidence of local recurrence or metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observation of the normalization rate of jaundice resolution and recovery of serum total bilirubin after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploring the optimal course of treatment for jaundice with different indications using Babaodan capsules based on stratified analysis of treatment duration (7-14 days 15-21 days 22-28 days);Occurrence and rate of adverse events;Select patients with abnormal liver function indicators (ALT AST GGT ALP) and observe the normalization of liver function indicators after treatment;Observation of the normalization time for jaundice to subside and serum total bilirubin to return to normal after treatment;Observe the superior combination of Babaodan capsule combined with traditional Chinese patent medicines and simple preparations or traditional Chinese medicine in the treatment of jaundice or the superior disease of the same combination in the treatment of jaundice;By analyzing different indications and traditional Chinese medicine syndromes clarify the advantageous diseases or syndrome types of Baobao Dan capsules in treating liver disease jaundice; | — |
Countries
China
Contacts
Public ContactXu Chunjun
Beijing Hospital of Traditional Chinese MedicineCapital Medical University
Outcome results
None listed