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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004552
Receipt No. R000005440
Scientific Title A comparative trial on adjuvant and clinical effects of influenza vaccine by Kampo formulas in elderly people.
Date of disclosure of the study information 2010/11/15
Last modified on 2012/06/18

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Basic information
Public title A comparative trial on adjuvant and clinical effects of influenza vaccine by Kampo formulas in elderly people.
Acronym Effect of Kampo formulas on adjuvant effects of influenza vaccine.
Scientific Title A comparative trial on adjuvant and clinical effects of influenza vaccine by Kampo formulas in elderly people.
Scientific Title:Acronym Effect of Kampo formulas on adjuvant effects of influenza vaccine.
Region
Japan

Condition
Condition Influenza
Classification by specialty
Pneumology Infectious disease Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the adjuvant effects of influenza vaccine by Kampo formulas in elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Various sorts of influenza antibody value.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Oral administration of hochuekkito
Interventions/Control_2 Oral administration of juzentaihoto
Interventions/Control_3 Oral administration of hachimijiogan
Interventions/Control_4 Oral administration of ogikenchuto
Interventions/Control_5 Non-administration of Kampo formulas
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Influenza vaccine recipients.
Key exclusion criteria 1. Patients with severe diseases whose serum albumin level is under 2.7 g/dl or concentration of hemoglobin is under 9.0 g/dl.
2. Patients with infections who continue the fever above 38 degrees C
3. Patients who take medicines that have influences on antibody productions for instance steroid preparation and immune -suppressive agents.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirozo Goto
Organization University of Toyama
Division name Department of Japanese Oriental Medicine, Graduate school of Medicine and Pharmaceutical Sciences
Zip code
Address 2630 Sugitani, Toyama, Japan
TEL 076-434-7393
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirozo Goto
Organization University of Toyama
Division name Department of Japanese Oriental Medicine, Graduate school of Medicine and Pharmaceutical Sciences
Zip code
Address 2630 Sugitani, Toyama, Japan
TEL 076-434-7393
Homepage URL
Email

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare,
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 サンバリー高岡病院(富山県)、となみ三輪病院(富山県)、吉見病院(富山県)
二之沢病院(群馬県)、県央病院(群馬県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 15 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
2010 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 07 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 12 Day
Last modified on
2012 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005440

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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