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
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
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
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
