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



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:5/3/2014
Start Date:September 2011
End Date:August 2013

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate 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
We found this trial at
28
sites
San Carlos, California 94070
?
mi
from
San Carlos, CA
Click here to add this to my saved trials
2147 Northeast Coachman Road
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
701 West Morse Boulevard
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45014
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Corona, California 92880
?
mi
from
Corona, CA
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Hollis, New York 11423
?
mi
from
Hollis, NY
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
Ocean Springs, Mississippi 39564
?
mi
from
Ocean Springs, MS
Click here to add this to my saved trials
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Quincy, Massachusetts 02169
?
mi
from
Quincy, MA
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
St. Louis, Missouri 63128
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
Troy, Michigan 48098
?
mi
from
Troy, MI
Click here to add this to my saved trials
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials