Benefit of glucosyl Hesperidin in patients with primary biliary cholangitis: amulticenter, open-label, randomized control study

Fujinaga Yukihisa0 个研究点目标入组 110 人开始时间: 2022年3月30日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•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

•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

发起方

Fujinaga Yukihisa