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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003941
Receipt No. 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

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Basic information
Public title Clinical evaluation of Misatol (MK615), extract from Japanese apricot "Prunus Ume", for ulcerative colitis patients: A mono-center open trial.
Acronym Unique supplement, Misatol, for ulcerative colitis; a preliminary clinical Evaluation Trial (UME-trial)
Scientific Title Clinical evaluation of Misatol (MK615), extract from Japanese apricot "Prunus Ume", for ulcerative colitis patients: A mono-center open trial.
Scientific Title:Acronym Unique supplement, Misatol, for ulcerative colitis; a preliminary clinical Evaluation Trial (UME-trial)
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the remission induction and maintenance efficiencies of peroral administration of Misatol in ulcerative colitis patients by mono-center open trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients should take Misatol (6.5g/pack) 2 packs (before breakfast and dinner) per day during one year.
Interventions/Control_2 Patients should not take Misatol during one year.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
76 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nakamra
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL 0798-45-6660
Email shiro@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Fukunaga
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa, Nishinomiya,
TEL 0798-45-6662
Homepage URL
Email kebe@hyo-med.ac.jp

Sponsor
Institute Department of lower gastroenterology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Department of lower gastroenterology, Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2012 Year 11 Month 30 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 23 Day
Last modified on
2013 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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