Primary Biliary Cholangitis Cholangitis
Conditions
Interventions
Participants will be randomly assigned to standard dose and high dose groups.
In standard dose group, hesperidin tablet 500 mg (two tablets at a time once a day after meal) will be orally administered
Sponsors
Fujinaga Yukihisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary biliary cholangitis 2. 20 years old or older at the time of consent acquisition 3. Patients with performance status (ECOG) 0 or 1 4. Patients without dose change of ursodeoxycholic acid (UDCA) and fibrate 5. Patients who received sufficient explanation about the contents of this study and voluntarily obtained written consent from the study subject or the surrogate
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to hesperidin 2. Patients who routinely take health foods containing hesperidin before participating in this study 3. Patients scheduled or under treatment for malignant tumors 4. Patients with NYHA functional classification 2 or higher 5. Patients who become aware of dyspnea during daily exertion 6. Patients with a total bilirubin level of 3.0 mg / dl or higher or Child-Pugh classification B or C 7. Patients with eGFR <30 mL / min / 1.73 m2 8. Patients who are pregnant or may be pregnant 9. Patients who participated in other clinical trials (clinical trials) within 3 months before the start of hesperidin administration 10. Patients judged by doctors to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in biliary enzyme level (serum GGT) from 0 to 24 weeks after administration of hesperidin | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of change in biliary enzyme level (serum GGT) from 0 to 8 and 16 weeks after administration of hesperidin 2) Rate of change in hepatobiliary enzyme level (serum ALP, AST, ALT and total bilirubin) from 0 to 8, 16 and 24 weeks after administration of hesperidin 3) Rate of change in protein expression level (Nrf2 and HMOX-1 genes) from 0 to 8, 16 and 24 weeks after administration of hesperidin | — |
Contacts
Public ContactKoh Kitagawa
Nara Medical University Hospital
Outcome results
None listed