Unique ID issued by UMIN | UMIN000004401 |
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Receipt number | R000005260 |
Scientific Title | A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis |
Date of disclosure of the study information | 2010/10/18 |
Last modified on | 2013/04/15 09:19:52 |
A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis
Efficiency of Chinese Herbal-suppository for Active Ulcerative Proctitis
A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis
Efficiency of Chinese Herbal-suppository for Active Ulcerative Proctitis
Japan |
Ulcerative colitis (Proctitis type)
Medicine in general | Gastroenterology |
Others
NO
In order to evaluate efficacy and safety of a newly developed suppository medicine containing a Chinese herbal-medicine (Xilei San) for active ulcerative proctitis patients refracting current other medication(s) because of adverse event and/or ineffectiveness.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
Remission rate at 24 weeks after the start of protocol treatment
(Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)
Evaluation of efficiency: Remission ratios at 48 weeks after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the Rachmilewitz clinical activity index (CAI) and Endoscopic index (EI), Liley histological score, and evaluation of patients QOL using IBDQ, etc.
Evaluation of safety: Adverse event, Abnormal values in blood test, etc.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Placebo arm:
A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks).
True arm:
A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study period
16 | years-old | <= |
75 | years-old | >= |
Male and Female
1. A patient who is diagnosed as ulcerative colitis.
2. A patient who has been diagnosed as active UC with disease extension of within 15cm from anus by either endoscopic or roentgenogram examination within 4 weeks.
3. A patient who refracted more than 4 weeks of conventional topical therapy prior to enroll the trial.
4. A patient who is expected to suffer from severe adverse effect of the conventional therapy, i.e. 5-ASA and/or steroid, by reason of his (her) past history or other. (judged by a doctor in charge)
5. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement. (If a patient is under 20 years old, a signature of his (her) legal representative is necessary.)
1. A patient who has had hypersensitivity to Chinese medicine.
2. A patient who has had an episode of severe hypersensitivity to food.
3. A patient who has complicated severe heart, kidney, respiratory, and metabolic disease.
4. A patient, who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period.
5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
30
1st name | |
Middle name | |
Last name | Takayuki Matsumoto |
Hyogo College of Medicine
Lower GI disease
1
0798-45-6660
1st name | |
Middle name | |
Last name | Ken Fukunaga |
Hyogo College of Medicine
Lower GI disease
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
0798-45-6662
kebe@hyo-med.ac.jp
Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease
Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease
Self funding
NO
2010 | Year | 10 | Month | 18 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/22775479
Completed
2007 | Year | 05 | Month | 08 | Day |
2007 | Year | 06 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 10 | Month | 18 | Day |
2013 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005260
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