UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on the clinical course and treatment effect based on QOL evaluation in seasonal influenza
Title of the study (Brief title)	The QOL study in seasonal influenza
Region	Japan

Condition
Condition	Seasonal influenza
Classification by specialty	Medicine in general Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To show the clinical course and treatment effect based on QOL evaluation in seasonal influenza
Basic objectives2	Others
Basic objectives -Others	To show whether or not there is a difference between the change of symptoms and that of QOL
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The change of QOL score evaluated by questionnaire
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Influenza patients
Key exclusion criteria	Patients who admitted over 48hours after initiation of symptoms.
Target sample size	55

Research contact person
Name of lead principal investigator	Yusuke Yoshino
Organization	Teikyo university hospital
Division name	Internal medicine
Address	2-11-1, Kaga, Itabashi, Tokyo
TEL	0339641211
Email	yyoshino@med.teikyo-u.ac.jp

Public contact
Name of contact person	Yusuke Yoshino
Organization	Teikyo university hospital
Division name	Internal medicine
Address	2-11-1, Kaga, Itabashi, Tokyo
TEL	0339641211
Homepage URL
Email	yyoshino@med.teikyo-u.ac.jp

Sponsor
Institute	Department of Internal Medicine, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Department of Internal Medicine, Teikyo University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	TUIC-COI 18-0760
Org. issuing International ID_1	Teikyo University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	帝京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 15 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 04 Month 30 Day
Date trial data considered complete	2022 Year 05 Month 31 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is prospective observational study. We plan to evaluate patient's status by using questionnaire. We plan to ask patients to send their questionnaire by mail or e-mail twice, one and two weeks after the initiation of observation.

Management information
Registered date	2018 Year 11 Month 15 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039526