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