A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 79
- 试验地点
- 27
- 主要终点
- Clinical response as measured by a reduction in the CDAI total score
研究概览
简要总结
The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.
详细描述
Crohn's disease, a chronic condition resulting in inflammation of the gastrointestinal tract (GI), causes a person to experience persistent symptoms of inflammatory bowel disease, including abdominal pain, nausea, vomiting, rectal bleeding, diarrhea, and constipation, with infrequent bowel movements that are at times accompanied by a sensation of incomplete emptying after having a bowel movement. Tsumura's TU-100 is a modern herbal product that has been approved as a prescription drug in Japan. Several lines of evidence indicate that TU-100 attenuates intestinal inflammation in Crohn's disease by increasing intestinal blood flow and stimulating a protective lining of intestinal mucus which produces an anti-inflammatory effect. TU-100 may attenuate pathological changes in the intestine and reduce symptoms in patients with Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provide written informed consent
- •ability to orally ingest study medication
- •male or female between 18 to 75 inclusive
- •diagnosed with Crohn's disease for at least 3 months
- •CDAI score of 220-300 at screening
- •sexually active participants of childbearing potential must agree to birth control
- •no clinically significant conditions which the doctor would feel exclusionary
- •stable medication (including probiotics)
排除标准
- •history of any bowel condition that may interfere with the evaluation of the study drug
- •positive stool cultures
- •currently pregnant or lactating
- •receiving total parenteral nutrition
- •history of alcohol or drug abuse within one year
- •history of malignancy within 5 years
- •current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics
- •treatment with Anti-TNF agents 12 weeks before screening
- •treatment with corticosteroids four weeks prior to screening
- •treatment with cyclosporine or tacrolimus eight weeks prior to screening
- •presence of a poorly controlled medical condition
- •history of allergic reaction to ginseng, ginger or sichuan pepper
- •any use of supplemental ginger, ginseng and Sichuan powder 2 weeks prior to and through course of the trial
- •current use of any of the following herbal medications: Boswellia, Cat's claw (Uncaria tomentosa), Cayenne pepper, Echinacea, Horsetail (Equisetum), Hops, Lady's mantle (Alchemilla), Marshmallow root (Althaea), Slippery elm (Ulmus rubra) Turmeric and White Willow (Salix alba)
- •history of celiac disease
- •current diagnosis of lactose intolerance
- •history of any other investigational medication within 30 days of enrolling in study
- •unsuitability as determined by the study doctor
研究组 & 干预措施
TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
干预措施: TU-100 (Drug)
Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Clinical response as measured by a reduction in the CDAI total score
时间窗: over eight weeks
次要结局
- CDAI reduction by number of points and difference from baseline(over eight weeks)
- proportion of subjects showing a clinical remission by measure of CDAI score(over eight weeks)
- The change in total CDAI score(every four weeks over eight weeks)
- The change in IBDQ total score and category sub-scores(every four weeks over eight weeks)
- The change in CRP level(every four weeks over eight weeks)
- The change in fecal calprotectin levels(over eight weeks)