UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006707 |
|---|---|
| Receipt number | R000007924 |
| Scientific Title | The examination of the utility of the Yokukansan for the insomnia to fibromyalgia |
| Date of disclosure of the study information | 2011/11/21 |
| Last modified on | 2017/04/17 16:28:03 |
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Basic information
Public title
The examination of the utility of the Yokukansan for the insomnia to fibromyalgia
Acronym
The examination of the utility of the Yokukansan for the insomnia to fibromyalgia
Scientific Title
The examination of the utility of the Yokukansan for the insomnia to fibromyalgia
Scientific Title:Acronym
The examination of the utility of the Yokukansan for the insomnia to fibromyalgia
Region
| Japan |
Condition
Condition
The fibromyalgia patients with insomnia
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation for the utility to the Yokukansan for the insomnia of fibromyalgia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Japanses Pittsburgh Sleep Quality Index(PSQI)
Key secondary outcomes
Japanses Fibromyalgia Impact Questionnaire
Japanses State-Trait Anxiety Inventory
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
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
| Medicine |
Interventions/Control_1
Remedy for Yukukannsan
Interventions/Control_2
Not remedy for Yukukannsan
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The paients of fybromyalgia for 1990 American College of Rheumatology diagnostic criteria.
2)Japanese Pittsburgh Sleep Quality Index point was over 6.
Key exclusion criteria
The patients with depression or dementia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1, Sugao Miyamae-ku, Kawasaki, Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School of Medicine
Division name
Neuropsychiatry
Zip code
Address
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School 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
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
| 2011 | Year | 11 | Month | 21 | 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
| 2011 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 11 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007924
