BIG STEP

JRCT ID: jRCTs051210210

Registered date:30/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary Biliary Cholangitis
• Date of first enrollment: 30/03/2022
• Target sample size: 110
• Study type: Interventional

Intervention(s)

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 for 24 weeks. In high dose group, hesperidin tablet 1000mg (four tablets at a time once a day after meal) will be orally administered for 24 weeks.

Outcome(s)

• Primary Outcome: Rate of change in biliary enzyme level (serum GGT) from 0 to 24 weeks after administration of hesperidin

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fujinaga Yukihisa
• Source(s) of Monetary Support: Nara Medical University