UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of girdle for chronic dry cough
Title of the study (Brief title)	HARAOBI study
Region	Japan

Condition
Condition	Chronic dry cough
Classification by specialty	Medicine in general Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy of girdle for chronic dry cough
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS(Visual analog scale) LCQ(Leicester Cough Questionnaire)
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	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	1
Key exclusion criteria	1
Target sample size	66

Research contact person
Name of lead principal investigator	Shigeki Nanjo
Organization	Kobe City Medidal Center General Hospital
Division name	Pulmonary Medicine
Address	4-6 Minatojima-nakamachi, Chuo-ku, Kobe 650-0046, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kobe City Medidal Center General Hospital
Division name	Pulmonary Medicine
Address
TEL	078-302-4321
Homepage URL
Email	shigekix@wg8.so-net.ne.jp

Sponsor
Institute	Kobe City Medidal Center General Hospital
Institute
Department

Funding Source
Organization	Kobe City medidal center General Hospital
Organization
Division
Category of Funding Organization	Self funding
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	神戸市立医療センター中央市民病院、先端医療センター、大阪市立総合医療センター

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 21 Day
Anticipated trial start date	2010 Year 04 Month 21 Day
Last follow-up date	2018 Year 10 Month 03 Day
Date of closure to data entry	2018 Year 10 Month 03 Day
Date trial data considered complete	2018 Year 10 Month 03 Day
Date analysis concluded	2018 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 07 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004338