A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
- Registration Number
- NCT01388933
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching placebo Matching Placebo Matching placebo given 5g three times daily orally for 8 consecutive weeks TU-100 TU-100 15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
- Primary Outcome Measures
Name Time Method Clinical response as measured by a reduction in the CDAI total score over eight weeks
- Secondary Outcome Measures
Name Time Method The change in CRP level every four weeks over eight weeks 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 fecal calprotectin levels over eight weeks
Related Research Topics
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Trial Locations
- Locations (27)
Atlanta Gastroenterology Associates, LLC
🇺🇸Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
TRIMED Clinical Trials
🇺🇸Corona, California, United States
Digestive Care Associates, LLC
🇺🇸San Carlos, California, United States
NY Scientific CORP
🇺🇸Hollis, New York, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Digestive Health Center
🇺🇸Ocean Springs, Mississippi, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Preferred Research Partners Inc
🇺🇸Little Rock, Arkansas, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Ohio Gastroenterology and Liver
🇺🇸Cincinnati, Ohio, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
University of Chicago Hospital Medical Center
🇺🇸Chicago, Illinois, United States
Metropolitan Gastroenterology Group. PC
🇺🇸Chevy Chase, Maryland, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
Rocky Mountain Gastroenterology Associates
🇺🇸Lakewood, Colorado, United States
Clinical Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Endoscopic Microsurgery Associates PA
🇺🇸Towson, Maryland, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
MedRACS
🇺🇸Quincy, Massachusetts, United States