Ulcerative colitis
Conditions
Interventions
Patients should take Misatol (6.5g/pack) 2 packs (before breakfast and dinner) per day during one year.
Patients should not take Misatol during one year.
Sponsors
Department of lower gastroenterology, Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who have diagnosed as ulcerative colitis. 2) Steroid refractory patients who experienced deterioration within at least last one year. 3) Patients who response other treatment. The Patients Lichiger index score decrease from higher than 4 to smaller than 3 and keep smaller 3 within three week. 4) Patients who could continue Misatol intake 2packs per day during one year. 5) Patients who could visit a research doctor once a month.
Exclusion criteria
Exclusion criteria: 1. Patients under 18 y.o and/or more than 76 y.o. 2. Patients who have been enrolled other clinical trial. 3. Patients who have not jugged as eligible by their doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lichtiger's CAI(clinical activity index) are evaluated at every monthly visit. Endoscopic UC activity is diagnosed by the Mayo index. Clinical and endoscopic activities are compared between taking and not-taking Misatol groups at 4, 24, and 48 weeks; also probability of sustained remission ratio of these groups should be analyzed and compared using the Kaplan Meier method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secretions of the peripheral cytokines are compared between pre and post trial. Safety observation is conducted at each visit, but within the coverage of national health insurance policy. Blood samplings Complete blood cell counts, AST (GOT), ALT (GPT), gamma-GTP, Alkaline phosphatase (ALP), Lactate dehydrogenase (LDH), Total-bilirubin, Total-cholesterol, etc. | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Department of lower gastroenterology
Outcome results
None listed