UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002676 |
|---|---|
| Receipt number | R000003257 |
| Scientific Title | Study on the effectiveness of Gingyo Gedokusan on influenza like illness (ILI) and swine origin influenza A (H1N1) |
| Date of disclosure of the study information | 2010/01/30 |
| Last modified on | 2012/04/27 13:34:04 |
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Basic information
Public title
Study on the effectiveness of Gingyo Gedokusan on influenza like illness (ILI) and swine origin influenza A (H1N1)
Acronym
Study of Gingyo Gedokusan on novel influenza
Scientific Title
Study on the effectiveness of Gingyo Gedokusan on influenza like illness (ILI) and swine origin influenza A (H1N1)
Scientific Title:Acronym
Study of Gingyo Gedokusan on novel influenza
Region
| Japan |
Condition
Condition
influenza like illness
swine origin influenza A
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effectiveness of Gingyo Gedokusan (herbal medicine) on so called novel influenza as well as ILI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
hospitalization and mortality within 7 days after presentation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gingyo Gedokusan
Interventions/Control_2
oseltamivir
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
| 16 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No underlying medical condition with organ damage
Key exclusion criteria
needs hospitalization
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwata |
Organization
Kobe University
Division name
Division of Infectious Diseases
Zip code
Address
Kusunoki-cho 7-5-1, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University
Division name
Division of Infectious Diseases
Zip code
Address
TEL
Homepage URL
kentaroiwata1969@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Rohto Corporation Co.,Ltd.
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
| 2010 | Year | 01 | Month | 30 | 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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 27 | Day |
Last modified on
| 2012 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003257
