UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001922 |
|---|---|
| Receipt number | R000002343 |
| Scientific Title | The exploratory analysis for the efficacy and safety of Rikkunshito for upper gastrointestinal symptoms in the patients with functional dyspepsia |
| Date of disclosure of the study information | 2009/05/01 |
| Last modified on | 2010/07/20 15:12:52 |
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Basic information
Public title
The exploratory analysis for the efficacy and safety of Rikkunshito for upper gastrointestinal symptoms in the patients with functional dyspepsia
Acronym
The analysis for the efficacy and safety of Rikkunshito for the patients with functional dyspepsia
Scientific Title
The exploratory analysis for the efficacy and safety of Rikkunshito for upper gastrointestinal symptoms in the patients with functional dyspepsia
Scientific Title:Acronym
The analysis for the efficacy and safety of Rikkunshito for the patients with functional dyspepsia
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of Rikkunshito
Basic objectives2
Others
Basic objectives -Others
The change of the level in the hormone related to appetite
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The upper gastrointestinal symptoms at 2 and 4 weeks after drug administartion
Key secondary outcomes
The change of the level in the hormone related to appetite at 2 and 4 weeks after drug administartion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rikkunshito
7.5g per day
before meal
4 weeks
Interventions/Control_2
Domperidone
30mg per day
before meal
4 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients diagnosed as functional dyspepsia by the Rome III criteria
Key exclusion criteria
The patients
(1)after removal of their stomach
(2)with heart failure or severe inflammation
(3)with disorder in liver, gallbladder, or pancreas
(4)with pregnancy, or breast-feeding now
(5)with astrointestinal bleeding, mechanical ileus, perforation in gastrointestine
(6)taking prohibited drug during trial
(7) impossible to take a drug per oral
(8)taking herbal medicine during trial
(9)who are unsuitable judged by the responsible person
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MAKOTO ARAI |
Organization
Graduate School of Medicine,
Chiba University
Division name
Medicine and Clinical Oncology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba-City, Japan
TEL
043-226-2083
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MAKOTO ARAI |
Organization
Graduate School of Medicine,
Division name
Medicine and Clinical Oncology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba-City, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
TSUMURA Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 30 | Day |
Last modified on
| 2010 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002343
