Further maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trial

Phase 2

• Conditions: lcerative colitis; Ulcerative colitis

• Registration Number: JPRN-jRCTs071180073
• Lead Sponsor: Kitazono Takanari

Brief Summary

The remission rate at 52 weeks after study enrolment in the continue group was significantly higher than in the discontinue group. Because the number of patients enrolled in the study was lower than predicted, it was difficult to continue the study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Study Completion: 2021-03-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1) Patients who undergo the treatment of Qing-Dai over a year
2) Patients whose disease activity is 1 or 0 by Mayo endoscopic score
3) Patients who received full-explanation and completely understood the study.
4) Patients with no change in treatment within the past 2 weeks before the commencement of the study
5) Patients with no change in treatment of ulcerative colitis during their oral administration of Qing-Dai
6) Patients who have voluntarily submitted written consent forms upon participation in this study

Exclusion Criteria

1)Pregnant or breastfeeding women
2)Patients who have a history of psychosomatic disorders
3)Patients who have a history of liver or renal diseases
4)Patients who have a history of antithrombotic therapy or thrombocytopenia
5)Patients who have a history of hepatitis B
6)Patients whom investigators and subinvestigators considered inappropriate to participate in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
remission rate after week 52 after initiation

Secondary Outcome Measures

Name	Time	Method
remission rate at week 152 after initiation, remission rate at week 4 after re-induction therapy