Ulcerative colitis
Conditions
Interventions
Oral Qing-Dai patients from 7 to 11 : twice a day(daily dose,1g) for 12 weeks patients from 12 to 14 :twice a day(daily dose,1.5g) for 12 weeks patients 15 and over: twice a day(daily dose,2g)
Sponsors
Kumamoto red cross hospital division of gatroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients from 7 to 80 Patients who had mild to moderate UC activity and were diagnosed according to the diagnostic criteria defined by the research group of inflammatory bowel disease in the Ministry of Health,Labor and Welfare in Japan.
Exclusion criteria
Exclusion criteria: colitis associated dysplasia, symptomatic intestinal stenosis a history of side effect or allergy of Chinese herbal medicine a need for potential surgery after enrollment in this study signs of other types of colitis, severe liver ,heart or renal diseases; or a history of malignant diseases, psychosomatic disorders,infectious disease. Pregnant or breastfeeding women. The patients treated with leukocyte aphaeresis,prednisolone >=40mg,adalimumab,tacrolimus or cyclosporine within 2 weeks before the commencement of the study. The patients treated with infliximab whitin 4 weeks before the commencement of the study. Changing the dose of mesalamine or prednisolone within 2 weeks before the commencement of the study. The patients treated with thiopurine within 12 weeks before the commencement of the study. Changing the dose of thiopurine within 4weeks before the commencement of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical response at 12 weeks of treatment The clinical response is defined as a decrease in the Mayo score of 1 or more in each item.The overall safety is assessed by the patients and investigators during the visit to the clinic. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of clinical remission and mucosal healing at 12weeks of treatment.Clinical remission is defined as a Mayo endoscopic score of 0 or 1 and other items of Mayo score of 0.Mucosal healing is defined as a Mayo endoscopic score of 0 or 1 .The serial changes in CAI score,Mayo score,partial Mayo score,Mayo endoscopic score,CRP are also assessed. | — |
Countries
Japan
Contacts
Public ContactTuyama Atuko
Kumamoto red cross hospital division of clinical support
Outcome results
None listed