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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388933
Recruitment Status : Terminated (Study stopped due to low enrollment)
First Posted : July 7, 2011
Last Update Posted : June 11, 2015
INC Research
Information provided by (Responsible Party):
Tsumura USA

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

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: TU-100 Drug: Matching Placebo Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
Drug: TU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
Other Name: Daikenchuto
Placebo Comparator: Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
Drug: Matching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Other Name: Placebo

Primary Outcome Measures :
  1. Clinical response as measured by a reduction in the CDAI total score [ Time Frame: over eight weeks ]

Secondary Outcome Measures :
  1. CDAI reduction by number of points and difference from baseline [ Time Frame: over eight weeks ]
  2. proportion of subjects showing a clinical remission by measure of CDAI score [ Time Frame: over eight weeks ]
  3. The change in total CDAI score [ Time Frame: every four weeks over eight weeks ]
  4. The change in IBDQ total score and category sub-scores [ Time Frame: every four weeks over eight weeks ]
  5. The change in CRP level [ Time Frame: every four weeks over eight weeks ]
  6. The change in fecal calprotectin levels [ Time Frame: over eight weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01388933

  Show 27 Study Locations
Sponsors and Collaborators
Tsumura USA
INC Research
Study Director: Shunji Mochida, Ph.D. Tsumura USA

Responsible Party: Tsumura USA Identifier: NCT01388933     History of Changes
Other Study ID Numbers: TU100P2T2
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: May 2015

Keywords provided by Tsumura USA:
Crohn's Disease
inflammatory bowel disease
Adult ages 18 to 75
Male and female subjects

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases