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

JRCT ID: jRCTs071180073

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 08/08/2017
• Target sample size: 40
• Study type: Interventional

Intervention(s)

arm A :stop oral administration of indigo naturalis
arm B :continue oral administration of indigo naturalis

Outcome(s)

• Primary Outcome: remission rate after week 52 after initiation
• Secondary Outcome: remission rate at week 152 after initiation, remission rate at week 4 after re-induction therapy

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitazono Takanari