Ulcerative colitis
Conditions
Interventions
control group:Placebo: receive placebo of Tiaochang Xiaoyan tablet (4 tablets per time, 4 times a day) and Shenlingbaizhu San capsule placebo (3 tablets each time, 3 times a day, orally) for 12 weeks,
follow-up for 36 weeks, visit once every 4 weeks
Intervention group:The treatment of traditional Chinese medicine with dispelling dampness prescription as the core was treated with Tiaochang Xiaoyan tablet (4 tablets each time, 4 times a day, orally
Sponsors
Guangdong Provincial Hospital of Chinese medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Patients with moderate and severe UC diagnosed. 2 The age is between 18 and 75. 3 It is suitable to be treated with Vidrizumab, a biological agent. 4 Those who have voluntarily participated in this study and have signed an informed consent form are in line with ethical principles.
Exclusion criteria
Exclusion criteria: 1 pregnant or lactating women, or those who plan pregnancy during the study cycle. 2 inflammatory bowel disease has serious complications, such as local stenosis, intestinal obstruction, intestinal perforation and so on. 3 patients with mental disorder and mental retardation. 4 those who are seriously ill and need urgent treatment. 5 severe active infections (such as tuberculosis, septicemia, cytomegalovirus infection, Listeria monocytogenes infection) and opportunistic infections (such as progressive multifocal leukoencephalopathy). 6 patients who are known to be allergic to the drugs used in this study and who contain related drug components. 7 those who are participating in clinical trials of other drugs or who have participated in other clinical trials within 4 weeks. The patients were treated with traditional Chinese medicine or proprietary Chinese medicine within 8 2 weeks, and within the half-life of 5 biological agents (such as Vidrizumab 25.5 days, enalapril 17.5 days, infliximab 50 days, adamumab 70 days, Usmumab 105 days, Skuciyou monoclonal antibody 135 days, etc.). 9 patients that the researchers believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptom score;TCM syndrome integral;Endoscopic response rate;Mucosal healing rate;Quality of life assessment;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactZhang Beiping
Department of Gastroenterology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed