UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036046
Receipt number R000041059
Scientific Title Evaluation of therapeutic efficacy for globus patients; randomized controlled trial
Date of disclosure of the study information 2019/02/28
Last modified on 2019/02/28 17:20:28

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Basic information

Public title

Evaluation of therapeutic efficacy for globus patients; randomized controlled trial

Acronym

Evaluation of therapeutic efficacy for globus patients; randomized controlled trial

Scientific Title

Evaluation of therapeutic efficacy for globus patients; randomized controlled trial

Scientific Title:Acronym

Evaluation of therapeutic efficacy for globus patients; randomized controlled trial

Region

Japan


Condition

Condition

Globus

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the therapeutic efficacy of the treatments for globus with randomized controlled trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation with visual analogue scale about subjective symptoms of globus

Key secondary outcomes

Evaluation with questionnaires; depression (SDS), anxiety (STAI), gastro-esophageal reflux (FSSG)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of Hangekobokuto

Interventions/Control_2

Oral administration of Rikkunshito

Interventions/Control_3

Oral administration of proton pump inhibitor (PPI)

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

The patients who were diagnosed as globus and agreed to participate in this trial.

Key exclusion criteria

The patients who didn't agree to participate in thes trial.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichiro Wasano

Organization

Japanese redcross Shizuoka hospital

Division name

Department of Otolaryngology

Zip code


Address

8-2 Outemachi, Aoi-ku, Shizuoka

TEL

054-254-4311

Email

wasano@a5.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichiro Wasano

Organization

Japanese redcross Shizuoka hospital

Division name

Department of Otolaryngology

Zip code


Address

8-2 Outemachi, Aoi-ku, Shizuoka

TEL

054-254-4311

Homepage URL


Email

wasano@a5.keio.jp


Sponsor or person

Institute

Japanese redcross Shizuoka hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

2019 Year 02 Month 28 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


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

2012 Year 12 Month 05 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 28 Day

Last modified on

2019 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name