Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis

Not Applicable

• Conditions: lcerative colitis

• Registration Number: JPRN-UMIN000024917
• Lead Sponsor: Kumamoto red cross hospital division of gatroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.