UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004552 |
|---|---|
| Receipt number | 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 17:43:47 |
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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
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
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005440
