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