A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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