UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015935 |
|---|---|
| Receipt number | R000018471 |
| Scientific Title | Exploratory trial for confirmation of safety on the mask with the ingredient of cinnamon bark extraction |
| Date of disclosure of the study information | 2015/01/12 |
| Last modified on | 2016/07/24 23:09:47 |
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Basic information
Public title
Exploratory trial for confirmation of safety on the mask with the ingredient of cinnamon bark extraction
Acronym
Trial for confirmation of saefty on the mask with the ingredient of cinnamon bark extraction
Scientific Title
Exploratory trial for confirmation of safety on the mask with the ingredient of cinnamon bark extraction
Scientific Title:Acronym
Trial for confirmation of saefty on the mask with the ingredient of cinnamon bark extraction
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate confirmation of safety on the mask with the ingredient of cinnamon bark extraction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mask loading ratio
Influenza infection
Fever
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
the mask with the ingredient of cinnamon bark extraction
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A person who is available with the mask for four weeks
2) A person who agrees with the participation for this study
Key exclusion criteria
1) A person who has an allergy to cinnamon bark
2) A person with the infectious disease that fever more than or equal to 38 degrees Celsius continues.
3) A person with bronchial asthma and serious respiratory diseases
4) A person who is pregnant or may be pregnant
5) Moreover, a person who is evaluated by doctor as an unsuitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAO NAMIKI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Japanese-Oriental (Kampo) Medicine,
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
+81-43-226-2984
tnamiki@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKAO NAMIKI |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Japanese-Oriental (Kampo) Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
+81-43-222-7171
Homepage URL
tnamiki@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Japanese-Oriental (Kampo) Medicine,Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Phytochemical 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
| 2015 | Year | 01 | Month | 12 | 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
Four out of 49 subjects withdrew. Side effects e.g. skin eruption were recognized in 14 subjects. However, the serious side effect was not recognized.
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
| 2014 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 13 | Day |
Last modified on
| 2016 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018471
