Ulcerative colitis
Conditions
Interventions
Vidrizumab induced remission phase:Patients diagnosed with moderate and severe active UC were treated with vedolizumab(300mg ivd) for 22 weeks.Endoscopy and related indicators were reexamined before t
endoscopic remission, Mayo endoscopy score = 1), it was included in the second phase of this clinical study.
Group treated with dispelling dampness prescription:Tiaochang Xiaoyan tablets (4 tablets per time, 4 times a day, orally) and Shenlingbaizhu San capsules (3 tablets per time, 3 times a day, orally) we
Group treated with dispelling dampness prescription placebo:The placebo of Tiaochang Xiaoyan tablet (4 tablets per time, 4 times a day) and The placebo of Shenlingbaizhu powder capsule (3 tablets eac
Sponsors
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Patients diagnosed with moderate and severe active UC ? The ages of between 18 and 75 ? Diagnosed as dampness syndrome based on the Evaluation scale of dampness Syndrome of traditional Chinese Medicine ? Suitable for Vedolizumab treatment ? Those who voluntarily participate in this study and have signed the informed consent form, the process of obtaining the informed consent form should be in accordance with ethical principles
Exclusion criteria
Exclusion criteria: ?Pregnant or lactating women, or those who plan pregnancy during the study cycle. ?Patients with Inflammatory bowel disease has serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, etc. ?Patients with mental disorders and mental retardation. ?Those who are seriously ill and need urgent treatment. ?Patients with severe active infections (e.g. tuberculosis, septicemia, cytomegalovirus infection, listeria infection) and opportunistic infections (e.g. progressive multifocal leukoencephalopathy). ?Patients who are known to be allergic to the drugs and related drug ingredients used in this study. ?Those who are participating in clinical trials of other drugs or who have participated in other clinical trials within 4 weeks. ?Patients who were treated with traditional Chinese medicine or proprietary Chinese medicine within 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.). ?Patients that the researchers believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual symptom score;Chinese medicine symptom complex score;Endoscopic response rate;Mucosal healing rate;Quality of life assessment; | — |
Countries
China
Contacts
Public ContactZhang Beiping
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed