A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat 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