臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 13, 2009
Last modified on	April. 18, 2017
Trial ID	jRCT1092220033

Scientific Title	Double-blind sham device-controlled multi-center crossover trial of chlorine dioxide gas on the protective effect against respiratory infections (Cleverin test)
Public Title	A test of a deodorant device on the protection of flu

Contact for Scientific Queries	Investigator Name	Norio Ogata
	Investigator Organization	Taiko Pharmaceutical Co., Ltd.
	Address	3-34-14 Uchihonmachi, Suita, Osaka 564-0032
	TEL	+81-6-6382-3100
	E-mail	nogata7@yahoo.co.jp
Contact for Public Queries	Contact Name	Norio Ogata
	Contact Organization	Taiko Pharmaceutical Co., Ltd.
	Address	3-34-14 Uchihonmachi, Suita, Osaka 564-0032
	TEL	+81-6-6382-3100
	E-mail	ogata@seirogan.co.jp

Recruitment Status	RECRUITING

Date of First Enrollment		Oct. 20, 2009
Planned Number of Subjects		1500
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Multi-center placebo-controlled randomized double-blind crossover study
	Type of Control
	Trial Blinding Schema	double blind
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Those who agree with the aim of this study.
	Exclusion Criteria	Those who do not agree with the aim of this study.
	Minimum Age	50age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Respiratory infections (common cold, influenza, bronchitis, pharyngitis, laryngitis and pneumonia)
Intervention(s)		Intervention type:DEVICE Name of intervention:Low-concentration chlorine dioxide gas Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:OTHER Dose per administration: Not applicable. 1 Dosing frequency / Frequency of use:QW 1 Planned duration of intervention:2 months Intended dose regimen:Not applicable. detailes of teratment arms: Comparative intervention name:Sham device (air) Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:OTHER Dose per administration: Not applicable. 1 Dosing frequency / Frequency of use: 1 Planned duration of intervention:2 months Intended dose regimen:Not applicable.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Number of the incidence of respiratory infections
Secondary Outcome(s)		Deodorant effect of rooms.

Primary Sponsor	Taiko Pharmaceutical Co., Ltd.
Secondary Sponsor	b

Sources of funding	Taiko Pharmaceutical Co., Ltd.

Name of Ethics Committee	54
Address
TEL	+81-6-6345-2234
FAX	+81-6-6344-1123
E-Mail	nogata7@yahoo.co.jp
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	No
Reason for Unapproval	r

Date of approved	April. 19, 2005

-->

Secondary Study ID	s
Issuer Name

Secondary Study ID	g
Issuer Name	2

Secondary Study ID	23
Issuer Name	234

Secondary Study ID	d
Issuer Name	4

Secondary Study ID	r
Issuer Name	56

Secondary Study ID	JMA-IIA00033
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	April. 18, 2017	(this page)	Changes
1	Oct. 13, 2009	Detail

List of change history