UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013671 |
|---|---|
| Receipt number | R000015952 |
| Scientific Title | Examination of the Shoseiryuto for the migraine |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2020/02/21 20:55:02 |
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Basic information
Public title
Examination of the Shoseiryuto for the migraine
Acronym
Examination of the Shoseiryuto for the migraine
Scientific Title
Examination of the Shoseiryuto for the migraine
Scientific Title:Acronym
Examination of the Shoseiryuto for the migraine
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Medicine in general | Neurology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the Shoseiryuto in the migraine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Attack frequency
Key secondary outcomes
face scale
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
syouseiryutou
Interventions/Control_2
guide line therapy
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
Migraine
Key exclusion criteria
pregnacy
drug allergy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mitsufuji |
Organization
saitama medical university
Division name
Neurology
Zip code
350-0495
Address
38 Monohongo, Monoyama-Cho, Iruma-gun
TEL
0492761667
kobatake@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mitsufuji |
Organization
saitama medical university
Division name
Neurology
Zip code
350-0495
Address
morohonngou 38, moroyama irumagun Saitama
TEL
049-276-1208
Homepage URL
mitsufuj@saitama-med.ac.jp
Sponsor or person
Institute
saitama medical university
Institute
Department
Personal name
Funding Source
Organization
saitama medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital Hospital IRB
Address
Iruma, Moroyama, Morohongo 38Department of Respiratory Medicine
Tel
0492761354
birb@saitama-med.ac.jp
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
埼玉医科大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 08 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015952
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
