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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028514
Receipt No. R000032628
Scientific Title Effectiveness of Clarithromycin in Patients with Yellow Nail Syndrome
Date of disclosure of the study information 2017/08/04
Last modified on 2018/08/09

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Basic information
Public title Effectiveness of Clarithromycin in Patients with Yellow Nail Syndrome
Acronym Clarithromycin for yellow nail syndrome
Scientific Title Effectiveness of Clarithromycin in Patients with Yellow Nail Syndrome
Scientific Title:Acronym Clarithromycin for yellow nail syndrome
Region
Japan

Condition
Condition Yellow Nail Syndrome
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluated the effectiveness of
Clarithromycin against nail discoloration and respiratory manifestation in patients with Yellow Nail Syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of respiratory symptom and nail
color between before and after administration
of Clarithromycin
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Eligible patients had been diagnosed with
YNS, and were treated at NCGM between January 2005 and January 2016.
2. These patients received oral CAM.
Key exclusion criteria None
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suzuki Manabu
Organization National Center for Global Health and Medicine
Division name Respiratory Medicine
Zip code
Address 1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655, Japan
TEL 03-3202-7181
Email manabu@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suzuki Manabu
Organization National Center for Global Health and Medicine
Division name Respiratory Medicine
Zip code
Address 1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email manabu@nms.ac.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 04 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
This study showed that between CAM and the improvement of clinical manifestations (both at nail and respiratory level) suggested a possible relationship.
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
2017 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 06 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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