ulcerative colitis
Conditions
Interventions
administration of the suppository ,which contains 0.05g indigo naturalis, for 4 weeks
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are applied to the diagnostic criteria of ulcerative colitis(UC). 2)Patients with 2 points or more partial Mayo score. 3)Patients who only have proctitis with 2 points or more endoscopic Mayo score, or patients who have 0 or 1 points from discending colon to cecum. 4)18-year-old or older patients who agreed to this trial, and when patients who are younger than 20 years old, their legal representatives also have to agree to the trial.
Exclusion criteria
Exclusion criteria: 1.Patients who are clinically classified into severe or fulminant condition or have other conditions besides UC,such as infectious enteritis and so on. 2.Patients with symptomatic stenosis. 3.Patients who are planned to undergo surgery or patients who have experienced adverse effect or allergy of herbal medicines, and patients who have had herbal medicine which contains IN. 4.Patients with severe infection, severe heart disease,2.0 mg per dl or higher serum creatinine levels,2.0mg per dl or higher serum total bilirubin levels, 50IU per l or higher serum AST and ALT levels, malignant tumor or its previous history,and neuropsychiatric disorders. 5.Patients who have possibility of pregnancy, or patients in nursing, or patients who hope to get pregnant. 6.Patients who are decided to be inappropriate for other reason by attending doctors. 7.Exclusion criteria about concomitant drugs. Changing dose of oral 5 aminosalicylate(5ASA)within 2 weeks before registration.Use of suppository or enema of 5-ASA or steroid within 2 weeks before registration.Receiving Granulocyte Monocyte Apheresis within 2 weeks before registration.Starting immunomodulators (azathioprine and 6-mercaptopurine),and changing dose of them within 4 weeks before registration.Use of 20mg or more of oral prednisolone or equivalent corticosteroid (the route: intravenous, intra-arterial , or intramuscular administration) within 2 weeks before registration. As for patients who receive 20mg or less oral prednisolone (or equivalent corticosteroid), changing dose or administration of oral prednisolone within 2 weeks before registration.Use of adalimumab within 4 weeks before registration.Use of infliximab or vedolizumab within 8 weeks before registration.Use of ustekinumab or herbal medicines other than IN within 12 weeks before registration.Use of cyclosporine (oral or intravenous administration) or tacrolimus (except for eye drops) within 2 weeks before registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety for 4 weeks after starting the treatment | — |
Countries
Japan
Contacts
Public ContactMakoto Naganuma
Keio University School of Medicine Gastroenterology and Hepatology
Outcome results
None listed