Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Centella Asiatica Supplement for Ulcerative Colitis - UCCA Study

Tsuchiya Kiichiro0 个研究点目标入组 10 人开始时间: 2022年8月31日最近更新: 2024年4月23日

试验速览

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•1) Patients who have been diagnosed with ulcerative colitis for at least 6 months
•2) Patients with a Partial Mayo score of 0-6 (mild to moderate disease) and a Mayo endoscopic subscore of 1 or higher
•3) Patients aged 18 years or older
•4) Patients with ECOG Performance status 0-2
•5) Patients who have been fully informed about the study and who have given their voluntary written consent based on their full understanding of the study.

•1) Patients diagnosed by lower gastrointestinal endoscopy as having an apparent cause of other diseases
•2) Patients who have changed or are scheduled to change their ulcerative colitis medication in the 2 weeks prior to enrollment or 4 weeks after enrollment (a change in ulcerative colitis medication is considered an exacerbation of ulcerative colitis or the appearance of serious side effects of that medication)
•3) Patients who are regular users of tuberculosis or formulation components
•4) Patients with or suspected of having toxic megacolon or gastrointestinal perforation
•5) Patients with other diseases that are poorly controlled at the time of enrollment
•6) Patients with serious liver disease
•7) Patients with serious renal disease
•8) Patients with a history of hypersensitivity to Centella Asiatica or any of the ingredients of the formulation.
•9) Pregnant women or women who may be pregnant
•10) Women who are breast-feeding
•11) Other patients who are judged to be inappropriate as subjects by the investigators.

发起方

Tsuchiya Kiichiro