UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory trial for confirmation of safety on the mask with the ingredient of cinnamon bark extraction
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	TAKAO NAMIKI
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Japanese-Oriental (Kampo) Medicine,
Address	1-8-1 Inohana Chuo-ku, Chiba
TEL	+81-43-226-2984
Email	tnamiki@faculty.chiba-u.jp

Public contact
Name of contact person	TAKAO NAMIKI
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Japanese-Oriental (Kampo) Medicine
Address	1-8-1 Inohana Chuo-ku, Chiba
TEL	+81-43-222-7171
Homepage URL
Email	tnamiki@faculty.chiba-u.jp

Sponsor
Institute	Department of Japanese-Oriental (Kampo) Medicine,Graduate School of Medicine, Chiba University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018471