UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037705 |
|---|---|
| Receipt number | R000043002 |
| Scientific Title | Examination of the pain relief effect of Goreisan for glossodynia with dry mouth 2 |
| Date of disclosure of the study information | 2019/08/16 |
| Last modified on | 2021/02/15 09:30:45 |
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Basic information
Public title
Examination of the pain relief effect of Goreisan for glossodynia with dry mouth 2
Acronym
Examination of the pain relief effect of Goreisan for glossodynia 2
Scientific Title
Examination of the pain relief effect of Goreisan for glossodynia with dry mouth 2
Scientific Title:Acronym
Examination of the pain relief effect of Goreisan for glossodynia 2
Region
| Japan |
Condition
Condition
Glossodynia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the degree of pain reduction effect of Goreisan administration in patients who are diagnosed with glossodynia with dry mouth and are undergoing treatment in the dental anesthesiology department.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-filled pain scale (VAS)
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
| Medicine |
Interventions/Control_1
Goreisan
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) Patients who have been diagnosed with glossodynia with dry mouth and are undergoing treatment at the oral pain liaison outpatient department of Nagasaki University Hospital
2)Age: Adult patients older than 20 years old when obtaining consent
3)Gender: Any
4) Hospitalization / Outpatient: Outpatient only
5)Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding
Key exclusion criteria
1) Patients taking Chinese medicine other than Gojosan
2)Patients with severe hypertension whose diastolic blood pressure is 120mmHg or more
3) Patients with severe liver and renal dysfunction
4) Patients with allergies and other drug sensitivity
5) Pregnant women and patients who may be pregnant or breastfeeding
6) Other patients who are deemed inappropriate by the research director
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | TAKAO |
| Middle name | |
| Last name | AYUSE |
Organization
nagasaki university
Division name
Deantal Anesthesia
Zip code
8528588
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197713
ayuse@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKAO |
| Middle name | |
| Last name | AYUSE |
Organization
Nagasaki University Hospital
Division name
Deantal Anesthesia
Zip code
8528588
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197713
Homepage URL
ayuse@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto Nagasaki
Tel
0958197713
0958197713
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 | 08 | Month | 16 | 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
| Delay expected |
Results Delay Reason
delay in analysis
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
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | 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 | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043002
