UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028514
Receipt number 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 22:21:19

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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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

Value
https://center6.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