Unique ID issued by UMIN | UMIN000003941 |
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Receipt number | R000004743 |
Scientific Title | Clinical evaluation of Misatol (MK615), extract from Japanese apricot "Prunus Ume", for ulcerative colitis patients: A mono-center open trial. |
Date of disclosure of the study information | 2010/07/26 |
Last modified on | 2013/12/16 09:10:32 |
Clinical evaluation of Misatol (MK615), extract from Japanese apricot "Prunus Ume", for ulcerative colitis patients: A mono-center open trial.
Unique supplement, Misatol, for ulcerative colitis; a preliminary clinical Evaluation Trial (UME-trial)
Clinical evaluation of Misatol (MK615), extract from Japanese apricot "Prunus Ume", for ulcerative colitis patients: A mono-center open trial.
Unique supplement, Misatol, for ulcerative colitis; a preliminary clinical Evaluation Trial (UME-trial)
Japan |
Ulcerative colitis
Medicine in general | Gastroenterology |
Others
NO
To evaluate the remission induction and maintenance efficiencies of peroral administration of Misatol in ulcerative colitis patients by mono-center open trial.
Safety,Efficacy
Exploratory
Pragmatic
Phase I
Lichtiger's CAI(clinical activity index) are evaluated at every monthly visit.
Endoscopic UC activity is diagnosed by the Mayo index.
Clinical and endoscopic activities are compared between taking and not-taking Misatol groups at 4, 24, and 48 weeks; also probability of sustained remission ratio of these groups should be analyzed and compared using the Kaplan Meier method.
Secretions of the peripheral cytokines are compared between pre and post trial.
Safety observation is conducted at each visit, but within the coverage of national health insurance policy.
Blood samplings
Complete blood cell counts, AST (GOT), ALT (GPT), gamma-GTP, Alkaline phosphatase (ALP), Lactate dehydrogenase (LDH), Total-bilirubin, Total-cholesterol, etc.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Food |
Patients should take Misatol (6.5g/pack) 2 packs (before breakfast and dinner) per day during one year.
Patients should not take Misatol during one year.
18 | years-old | <= |
76 | years-old | > |
Male and Female
1) Patient who have diagnosed as ulcerative colitis.
2) Steroid refractory patients who experienced deterioration within at least last one year.
3) Patients who response other treatment. The Patients Lichiger index score decrease from higher than 4 to smaller than 3 and keep smaller 3 within three week.
4) Patients who could continue Misatol intake 2packs per day during one year.
5) Patients who could visit a research doctor once a month.
1. Patients under 18 y.o and/or more than 76 y.o.
2. Patients who have been enrolled other clinical trial.
3. Patients who have not jugged as eligible by their doctors.
20
1st name | |
Middle name | |
Last name | Shiro Nakamra |
Hyogo College of Medicine
Department of lower gastroenterology
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
0798-45-6660
shiro@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Ken Fukunaga |
Hyogo College of Medicine
Department of lower gastroenterology
1-1 Mukogawa, Nishinomiya,
0798-45-6662
kebe@hyo-med.ac.jp
Department of lower gastroenterology, Hyogo College of Medicine
Department of lower gastroenterology, Hyogo College of Medicine
Self funding
NO
兵庫医科大学病院(兵庫県)
2010 | Year | 07 | Month | 26 | Day |
Unpublished
Terminated
2010 | Year | 07 | Month | 23 | Day |
2010 | Year | 07 | Month | 01 | Day |
2012 | Year | 11 | Month | 30 | Day |
2013 | Year | 03 | Month | 31 | Day |
2010 | Year | 07 | Month | 23 | Day |
2013 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004743
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