Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRC

REPHA GmbH0 个研究点开始时间: 2008年11月12日最近更新: 2013年5月20日

适应症

试验速览

暂无简介。

•-patients of both gender, = 18 years of age
•-patients diagnosed with ulcerative colitis (clinical, endoscopic, histological) and in remission between 1 week and 1 year according to colitis activity index (CAI, defined by Rachmilewitz) = 4 at enrollment
•-signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-use of steroids or antibiotics for ulcerative colitis together with the investigational procuct
•-intake of Escherichia coli Nissle and Psyllii semen together with the investigational product
•-administration of the following drugs within the previous 3 months before trial entry and during the trial: 'biologicals' (Infliximab, Mycophenolat, Tacrolimus, Thalidomid), other drugs to modify immune response (Methotrexat, Azathioprin) or/and drugs in clinical development
•-total parenteral nutrition, formula diet
•-infectious or chronic active ulcerative colitis
•-active ulcerative colitis at trial entry
•-condition after complete colectomy
•-malignant tumor disease within the last 5 years and/or malignant tumor disease older than 5 years which can not be considered cured according to the investigator's judgement (except superficial basal cell, squamous cell carcinoma, or basalioma of the skin which has been completely resected or can be considered cured) or/and clinical significant cardiac, hepatic or renal dysfunctions or diseases of the CNS, lung, immune system or gastro-intestinal diseases (in addition to ulcerative colitis)
•-known alcohol or drug abuse
•-known intolerance to the ingredients
•-pregnancy or in the physician's opinion unreliable contraception for women of childbearing years

发起方

REPHA GmbH