Clinical Trial: A Clinical Trial of Saireito for the Prevention of High-Output Stoma in Patients with Temporary Ileostomy after Surgery for Ulcerative Colitis (Japan)

Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060810) titled 'A Clinical Trial of Saireito for the Prevention of High-Output Stoma in Patients with Temporary Ileostomy after Surgery for Ulcerative Colitis' on May 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine,

Condition: Condition - ulcerative colitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate whether postoperative administration of Saireito (TJ-114) reduces the incidence of high-output stoma (HOS) in patients who undergo surgery for ulcerative colitis with the creation of a temporary ileostomy. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Saireito (Tsumura Saireito Extract Granules, TJ-114) will be administered orally at a dose of 9 g/day (3 g three times daily after meals) from postoperative day 2 (POD2) for 14 consecutive days. Concomitant use of other Kampo (traditional Japanese herbal) medicines will be prohibited during the intervention period. Standard perioperative management, including fluid therapy, dietary guidance, and antidiarrheal agents, will be provided according to institutional practice.

Eligibility: Age-lower limit - 18 years-old =18 years at the time of informed consent Patients considered capable of oral intake according to the postoperative management protocol Patients who have provided written informed consent to participate in the study Key exclusion criteria - History of hypersensitivity to Kampo medicines Patients judged to be unable to receive oral medication in the early postoperative period Severe hepatic dysfunction, severe heart failure, or other conditions judged inappropriate by the principal investigator Pregnant or breastfeeding women, or women who may be pregnant Any other condition deemed inappropriate for participation by the investigator Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069578

Disclaimer: Curated by HT Syndication.