Crohn's Disease
Conditions
Keywords
Crohn's Disease, natural, herbal, Kampo, inflammatory bowel disease, Adult ages 18 to 75, Male and female subjects
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.
Interventions
DRUGTU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
DRUGMatching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Sponsors
Syneos Health
Tsumura USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response as measured by a reduction in the CDAI total score | over eight weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| CDAI reduction by number of points and difference from baseline | over eight weeks |
| The change in CRP level | every four weeks over eight weeks |
| The change in fecal calprotectin levels | over eight weeks |
| The change in IBDQ total score and category sub-scores | every four weeks over eight weeks |
Countries
United States
Outcome results
None listed