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

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

Detailed Description
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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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: TU-100
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TU-100<br>15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily) | Drug: TU-100<br>* 15g daily, orally as 5g three times daily for 8 consecutive weeks<br>* Other names: Daikenchuto;|
| Placebo Comparator: Matching placebo<br>Matching placebo given 5g three times daily orally for 8 consecutive weeks | Drug: Matching Placebo<br>* 15g as 5g three times daily, orally for 8 consecutive weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response as measured by a reduction in the CDAI total score |  | over eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI reduction by number of points and difference from baseline |  | over eight weeks | 
| proportion of subjects showing a clinical remission by measure of CDAI score |  | over eight weeks | 
| The change in total CDAI score |  | every four weeks over eight weeks | 
| The change in IBDQ total score and category sub-scores |  | every four weeks over eight weeks | 
| The change in CRP level |  | every four weeks over eight weeks | 
| The change in fecal calprotectin levels |  | over eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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natural, Crohn's Disease, herbal, Kampo, inflammatory bowel disease, Adult ages 18 to 75, Male and female subjects