UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004549 |
|---|---|
| Receipt number | R000005437 |
| Scientific Title | A comparative trial on eradicative and clinical effects of Kampo formulas for multiply-resistant organisms in elderly bacterial carriers. |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2012/06/13 10:14:45 |
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Basic information
Public title
A comparative trial on eradicative and clinical effects of Kampo formulas for multiply-resistant organisms in elderly bacterial carriers.
Acronym
Effect of Kampo formulas on multiply-resistant organisms.
Scientific Title
A comparative trial on eradicative and clinical effects of Kampo formulas for multiply-resistant organisms in elderly bacterial carriers.
Scientific Title:Acronym
Effect of Kampo formulas on multiply-resistant organisms.
Region
| Japan |
Condition
Condition
Elderly bacterial carriers with multiply-resistant organisms.
Classification by specialty
| Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the eradicative effects of Kampo formulas on multiply-resistant organisms in elderly bacterial carriers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradicative rates of multiply-resistant organisms.
Key secondary outcomes
NK-cell activity
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of hochuekkito
Interventions/Control_2
Oral administration of juzentaihoto
Interventions/Control_3
Non-administration of Kampo formulas
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly bacterial carriers with multiply-resistant organisms.
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.
Target sample size
74
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）
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 | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 12 | Day |
Last modified on
| 2012 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005437
