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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
ChiCTR2100046346 |
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Date of registration:
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2021-05-14 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis
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Scientific title:
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A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis |
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Date of first enrolment:
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2021-06-01 |
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Target sample size:
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Ursodeoxycholic acid group:30;Rifaximin group :30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=126503 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Wang Kailing
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Address:
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87 Xiangya Road, Changsha, Hunan
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Telephone:
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+86 17805936121 |
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Email:
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wkling1998@163.com |
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Affiliation:
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Xiangya Hospital |
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Name:
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Liu Xiaowei
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Address:
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87 Xiangya Road, Changsha, Hunan
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Telephone:
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+86 13548762632 |
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Email:
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liuxw@csu.edu.cn |
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Affiliation:
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Xiangya Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 to 75 years;
2. Patients with newly-onset primary biliary cholangitis;
3. Volunteer to participate in this study and sign a written informed consent.
Exclusion criteria: 1. Have taken antibiotics in the past 2 months;
2. Take intestinal microecological preparations in the past 2 months;
3. Have a history of drinking in the past 3 months;
4. History of other liver diseases such as genetic metabolic diseases, hepatitis, liver cancer;
5. Infectious diarrhea, chronic diarrhea, irritable bowel syndrome, inflammatory diseases and other intestinal diseases;
6. Pregnant and lactating women;
7. Patients with serious mental illness, drug abuse, alcohol abuse, etc. who cannot cooperate with the study;
8. Those who have participated in any other clinical research within 1 month before entering the screening (Visit 1);
9. The investigator judges that any other diseases or conditions are not suitable for patients participating in this study.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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primary biliary cholangitis
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Intervention(s)
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Ursodeoxycholic acid group:Ursodeoxycholic acid;Rifaximin group :UDCA and rifaximin;
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Primary Outcome(s)
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liver function;Kidney function;Coagulation;Immunization full set;ANA Spectrum;Blood routine;
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Secondary Outcome(s)
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Anti-neutrophil antibody;
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Source(s) of Monetary Support
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National Natural Science Foundation of China
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Ethics review
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Status: Approved
Approval date: 12/04/2021
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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